Directory of Organizations and Associations 2142

December 1, 2008

30 Min Read
Directory of Organizations and Associations


Food and Drug Administration, Center for Devices and Radiological Health
Division of Small Manufacturers, International and Consumer Assistance
1350 Piccard Dr., HFZ-220
Rockville, MD 20850;
800/638-2041 or 240/276-3150
[email protected]

FDA, the primary government regulator of medical technology, holds authority over members of the medical device industry regarding safety and efficacy. All medical device manufacturers and some types of distributors must register with FDA annually and submit a list of the devices they distribute commercially. Manufacturers must also comply with FDA regulations, including those regarding marketing, clearance, manufacturing, quality control, labeling, distribution, and postmarket surveillance. The Division of Small Manufacturers, International and Consumer Assistance (DSMICA) helps manufacturers understand FDA regulations. DSMICA specialists answer questions over the phone, in person, or through written request. DSMICA also maintains a library of more than 1000 publications that can be obtained via the FDA Web site. The publications include FDA policy statements, manuals, guidances, and regulations. Manufacturers are encouraged initially to request assistance from an FDA District Office or an FDA Small Business Representative Office. There are 24 FDA District Offices, including three import offices, throughout the United States and Puerto Rico, as well as Small Business Representative Offices in New York City, Atlanta, Philadelphia, Dallas, and the San Francisco Bay Area.

Key phone numbers within the Center for Devices and Radiological Health:

  • Office of Compliance 240/276-0100

  • Office of Device Evaluation 240/276-3993

  • Division of Cardiovascular Devices 240/276-4000

  • Division of Anesthesiology, General Hospital, Infection Control and

  • Dental Devices 240/276-3700

  • Division of General, Restorative, and Neurological Devices 240/276-3737

  • Division of Ophthalmic and Ear, Nose, and Throat Devices 240/276-4200

  • Division of Reproductive, Abdominal, and Radiological Devices 240/276-3636

  • Office of Communication, Education, and Radiation Programs 240/276-3200

  • Office of Surveillance and Biometrics 240/276-3351

  • Office of Science and Engineering Laboratories 301/796-2781

The Adhesive and Sealant Council Inc. (ASC)
7101 Wisconsin Ave., Ste. 990,
Bethesda, MD 20814;
fax 301/986-9795 or; [email protected]
A North American trade association dedicated to representing the adhesive and sealant industry. Established in 1958, ASC is bound by the collective efforts of its members and strives to improve the industry operating environment and strengthen its member companies. ASC members account for more than 75% of the aggregate industry revenues, exceeding $6 billion annually.

Advanced Medical Technology Association (AdvaMed)
701 Pennsylvania Ave. N.W., Ste. 800,
Washington, DC 20004;
fax 202/783-8750; [email protected]
Represents more than 1200 innovators and manufacturers of medical devices, diagnostic products, and medical information systems. AdvaMed's members produce nearly 90% of the $75 billion worth of healthcare technology products consumed annually in the United States, and nearly 50% of the $175 billion worth purchased around the world annually.

American Association for Clinical Chemistry (AACC)
1850 K St. N.W., Ste. 625,
Washington, DC 20006;
fax 202/887-5093; [email protected]
An international scientific society of nearly 10,000 individuals who work in clinical laboratories or in the IVD industry. Members specialize in fields such as clinical chemistry, biochemistry, immunology, molecular pathology, medical technology, clinical pathology, toxicology, and laboratory management. Educational meetings are held throughout the year, culminating in an annual meeting and Clinical Lab Expo in late July. AACC is involved in government and regulatory affairs.

American Association for Homecare (AAHomecare)
2011 Crystal Dr., Ste. 725,
Arlington, VA 22202;
fax 703/836-6730; [email protected]
Works to strengthen Americans' access to home care. AAHomecare is a national association that represents the home-care community, including home medical equipment providers and manufacturers, respiratory therapies, rehabilitation and assistive technology, medical supplies, infusion therapy, medical gases, telemedicine, telehealth, and hospices. The association advocates on behalf of the home-care community in legislative and regulatory arenas. It also provides information and education forums for members.

American Institute for Medical and Biological Engineering (AIMBE)
1901 Pennsylvania Ave. N.W., Ste. 401,
Washington, DC 20006;
fax 202/466-8489; [email protected]
Founded in 1991 with the sponsorship of the National Science Foundation to establish an identity for medical and biological engineering. The institute offers a forum for research on policy issues related to the development and evaluation of the appropriate use of technology in medicine.

American National Standards Institute (ANSI)
1819 L St. N.W., 6th Fl.,
Washington, DC 20036;
fax 202/293-9287; [email protected]
A federation of organizations that establishes a national consensus on domestic and international standards and conformity assessment policy as it relates to trade, regulatory matters, and the integrity of the U.S. standards development system. ANSI approves American national standards and ensures that the group's guiding principles—consensus, due process, and openness—are followed by accrediting and auditing nearly 175 standards organizations.

The American Society for Clinical Laboratory Science (ASCLS)
6701 Democracy Blvd., Ste. 300,
Bethesda, MD 20817;
fax 301/657-2909; [email protected]
A large nonregistry professional association for nonphysician clinical laboratory professionals. Its 12,000 members include hematologists, phlebotomists, immunologists, immunohematologists, clinical chemists, microbiologists, managers, and educators.

American Society for Quality (ASQ)
600 N. Plankinton Ave.,
Milwaukee, WI 53203;
fax 414/272-1734; [email protected]
Source for information on the development, promotion, and application of quality strategies and techniques. The professional, not-for-profit association serves more than 130,000 individuals and 1000 sustaining members.

American Society for Testing and Materials (ASTM)
100 Barr Harbor Dr., P.O. Box C700,
West Conshohocken, PA 19428;
fax 610/832-9555; [email protected]
A primary source of voluntary standards for materials, products, systems, and services. The society's 33,000 members contribute time and expertise to the development and maintenance of standards and related technical information.

Association for the Advancement of Medical Instrumentation (AAMI)
1110 N. Glebe Rd., Ste. 220,
Arlington, VA 22201;
fax 703/276-0793; [email protected]
Organization for the development and use of medical technology. AAMI develops medical device standards using a program comprising more than 160 committees, 55 of which are international. It also is a primary source of quality system and GMP information and education. The association is a multidisciplinary alliance of professions, healthcare institutions, and industry, with the common goal of developing and using safe and effective medical instrumentation and related technologies.

Association of Medical Diagnostics Manufacturers (AMDM)
555 13th St., N.W., Ste. 7W-401,
Washington, DC 20004;
fax 202/637-5910; [email protected]
A nonprofit trade association serving as a resource for educational information on compliance issues for member companies and as an interface between member companies and FDA. Membership includes suppliers and consultants to the IVD industry as well as companies of all sizes that manufacture or distribute IVD products.

Biomedical Engineering Society (BMES)
8401 Corporate Dr., Ste. 140,
Landover, MD 20785;
fax 301/459-2444; [email protected]
A professional society for biomedical engineering and bioengineering. Members are leaders and decision makers in research, design, and applications of medical technology.

1275 Kinnear Rd.,
Columbus, OH 43212;
fax 614/675-3687; [email protected]
Founded in 1987, the nonprofit organization is designed to build the bioscience industry, research, and education in Ohio. Members are focused on networking bioscience assets to accelerate growth of global competitiveness. More than half of Ohio's 800 bioscience-related entities develop, test, or manufacture advanced medical technology products.

California Healthcare Institute (CHI)
1020 Prospect St., Ste. 310, La Jolla, CA 92037; 858/551-6677, fax 858/551-6688; [email protected]
A statewide public policy research and advocacy organization for California's biomedical industry. CHI's members include medical device, biotechnology, and pharmaceutical companies, as well as public and private research institutions. The organization advocates state and federal policies that promote scientific discovery and biomedical innovation.

Clinical Laboratory and Analytical Sciences (CLAS)
29003 Balmoral St.,
Garden City, MI, 48135;
fax 734/838-0420; [email protected]
A nonprofit international organization with an interest in establishing and promoting high standards in the science and application of ligand assay technology. The society encourages communication and cooperation among individuals in medical, pharmaceutical, academic, and industrial laboratories.

Controlled Release Society (CRS)
3340 Pilot Knob Rd.,
St. Paul, MN 55121;
fax 651/454-0766; [email protected]
A multidisciplinary society dedicated to the science and technology of controlled release and delivery, and to promoting knowledge of releasing science in order to deliver a better future.

Dental Trade Alliance
2300 Clarendon Blvd., Ste. 1003, Arlington, VA 22201; 703/379-7755, fax 703/931-9429; [email protected]
Trade group representing the dental industry in the United States. Members include distributors, laboratories, and manufacturers of supplies and equipment used in dental offices, laboratories, and schools.

Diagnostic Marketing Association (DxMA)
10293 N. Meridian St., Ste. 175,
Indianapolis, IN 46290;
fax 317/816-1633; [email protected]
A nonprofit professional organization of nearly 700 marketing and management professionals involved in marketing diagnostics and other medical products or services. DxMA offers seminars and an annual conference. It also presents marketing excellence awards.

ECRI Institute
5200 Butler Pike,
Plymouth Meeting, PA 19462;
fax 610/834-1275; [email protected]
A nonprofit health services research agency and a collaborating center of the World Health Organization. ECRI Institute provides information to the healthcare community to support safe and cost-effective patient care. It is an independent evaluator of medical devices and maintains databases on medical technologies.

Edison Welding Institute (EWI)
1250 Arthur E. Adams Dr.,
Columbus, OH 43221;
fax 614/688-5001; [email protected]
An engineering organization with engineering, technical, and support staff members with expertise in virtually every welding and joining technology available today for joining metals, ceramics, and plastics. EWI operates as a nonprofit industrial consortium, working with member companies to provide applied research, consultancy, training, and general technical support.

Electronic Industries Alliance (EIA)
2500 Wilson Blvd.,
Arlington, VA 22201-3834;
fax 703/875-8908;
A national trade organization representing U.S. electronic manufacturers. EIA represents the entire spectrum of companies involved in the manufacture of electronic components, parts, systems, and equipment.

Electrostatic Discharge Association
7900 Turin Rd., Bldg. 3,
Rome, NY 13440-2069;
fax 315/339-6793; [email protected]
A professional voluntary association dedicated to advancing the theory and practice of electrostatic discharge (ESD) avoidance. The association is broadening its scope to include other areas such as textiles and fully assembled electronic products.

Ethylene Oxide Sterilization Association Inc. (EOSA)
P.O. Box 33361,
Washington, DC 20033;
fax 202/557-3836; [email protected]
A trade organization for parties interested in ethylene oxide (EtO) and its diverse uses. Membership is open to any interested party, but EOSA's primary focus is to service medical and pharmaceutical companies, contract EtO sterilizers, gas sterilant suppliers, related users and suppliers, and consultants to the industry.

1155 15th St. N.W., Ste. 800,
Washington, DC 20005;
fax 202/371-0649; [email protected]
Provides educational seminars and workshops, issues publications and periodicals, and sponsors prestigious academic programs and symposia. Formerly known as the Food and Drug Law Institute, FDLI is a nonprofit, educational organization. Founded in 1949, its mission is to advance the public health by providing a neutral forum for the critical examination of the laws, regulations, and policies related to drugs, medical devices, other healthcare technologies, and foods.

Georgia Bio (GaBio)
1199 Euclid Ave.,
Atlanta, GA 30307;
fax 404/522-0132; [email protected]
A nonprofit organization with members from companies, universities, research institutes, governmentgroups, and other business organizations involved in the research and development of products to improve healthcare, agriculture, bioenergy and industrial production, environmental management, and biodefense. It is the Georgia state affiliate of the Biotechnology Industry Organization.

Health Industry Business Communications Council (HIBCC)
2525 E. Arizona Biltmore Cir., Ste. 127,
Phoenix, AZ 85016;
fax 602/381-1093; [email protected]
An industry-supported nonprofit organization. HIBCC's primary function is to facilitate electronic communications by developing
appropriate standards for information exchange among healthcare trading partners.

The Health Industry Council of the Dallas–Fort Worth Region
3001 Skyway Cir. N., Ste. 100,
Irving, TX 75038;
fax 972/570-8037; [email protected]
A nonprofit association founded to encourage health industry growth in the Dallas–Fort Worth region. The council gathers health industry data about the area, promotes industry conferences and conventions, and facilitates interaction among members of the healthcare community.

Health Industry Distributors Association (HIDA)
310 Montgomery St.,
Alexandria, VA 22314-1516;
fax 703/549-6495; [email protected]
A national business trade association representing medical products distributors. HIDA's role is to enhance the business performance of its member distributors. Through its annual conference, HIDA brings together healthcare device manufacturers with distributors serving the hospital, long-term care, physician or alternate care, and imaging markets.

Health Industry Representatives Association (HIRA)
7315 E. 5th Ave.,
Denver, CO 80230;
fax 303/341-0282; [email protected]
A trade association of independent contractor sales representatives in the healthcare industry. Members are manufacturers who support the continuing use of independent sales agencies to market their products.

Healthcare Communication & Marketing Association (HCMA)
19 Mantua Rd.,
Mt. Royal, NJ 08061;
fax 856/423-3420
A nonprofit, national association of healthcare marketing, communications, and education professionals dedicated to enhancing and optimizing the careers of its members. HCMA recognizes excellence in marketing, communications, and education that improves health.

Healthcare Convention and Exhibitors Association (HCEA)
1100 Johnson Ferry Rd., Ste. 300,
Atlanta, GA 30342;
fax 404/252-0774; [email protected]
An association of more than 600 organizations dedicated to improving the quality and return on investment of healthcare conventions and

IEEE Engineering in Medicine and Biology Society
445 Hoes Ln.,
Piscataway, NJ 08854;
fax 732/465-6435; [email protected]
Advances the application of engineering sciences and technology to medicine and biology. The Engineering in Medicine and Biology Society of IEEE promotes the profession and provides global leadership for the benefit of its members and humanity by disseminating knowledge, setting standards, and fostering professional development. It supports scientific, technological, and educational activities.

Indiana Medical Device Manufacturers Council Inc. (IMDMC)
P.O. Box 441385,
Indianapolis, IN 46244;
fax 317/974-1832; [email protected]
A trade association of companies and individuals involved in the manufacture of medical devices in Indiana. IMDMC focuses on training and education, legislative and regulatory issues, networking, and technology transfer. Meetings include business development briefings, regulatory and legislative roundtables, and presentations on
industry topics.

Institute of Environmental Sciences and Technology (IEST)
Arlington Place One, 2340 S. Arlington Heights Rd., Ste. 100,
Arlington Heights, IL 60005;
fax 847/981-4130; [email protected]
An international professional organization dedicated to enhancing process and product quality through the advancement of controlled environment technologies. The institute establishes and maintains standards and recommended practices and offers educational programs and communication forums.

Institute of Packaging Professionals (IoPP)
1601 Bond St., Ste. 101,
Naperville, IL 60563;
fax 630/544-5055; [email protected]
An individual membership organization in the packaging industry. IoPP offers a full program of membership services, including technical and news publications, professional development conferences, local chapter activities, an annual packaging design competition, and the only professional certification program in the packaging field.

International Society for Optical Engineering (SPIE)
1000 20th St.,
Bellingham, WA 98225;
fax 360/647-1445; [email protected]
An international nonprofit technical society. SPIE is dedicated to advancing the profession of optical engineering and promoting the scientific, engineering, and commercial development and application of optical, photonic, imaging, and optoelectronic technologies through its meetings, publications, education, and communications programs.

Life Science Alley
1550 Utica Ave. S., Ste. 725,
St. Louis Park, MN 55416;
fax 952/542-3088; [email protected]
A trade association serving the life sciences in the Upper Midwest. Life Science Alley represents approximately 600 member companies, organizations, and institutions that devote their efforts to the research, development, and commercialization of the life sciences. It acts as the industry's central resource for fostering innovation, providing education, and creating consensus. Life Science Alley offers unique opportunities for networking and collaboration and provides a strong, unified voice for its members on policy issues at state and federal levels.

Life Sciences Industries Council of the Buffalo Niagara Partnership
665 Main St., Ste. 200,
Buffalo, NY 14203-1487;
fax 716/852-2761; [email protected]
A not-for-profit membership association composed of many of western New York's health-related companies and organizations. It brings together manufacturers, distributors, providers, suppliers, and members from industry, universities, and hospitals.

Massachusetts Medical Device Industry Council (MassMEDIC)
715 Albany St., TW1,
Boston, MA 02118;
fax 617/414-1344; [email protected]
Formed in 1996 to promote the unique interests of the Bay State's medical device community. With more than 250 medical device companies, 56,000 industry workers, and annual sales in excess of $5 billion, Massachusetts is a center for medical device manufacturing. MassMEDIC's membership includes manufacturers, suppliers, teaching hospitals, research institutions, and government agencies.

Medical Device Manufacturers Association (MDMA)
1350 I St. N.W., Ste. 540,
Washington, DC 20005;
fax 202/349-7176; [email protected]
A national association that represents and serves independent manufacturers of medical devices, diagnostic products, and healthcare information systems. MDMA seeks to improve the quality of patient care by encouraging the development of new medical technology and fostering the availability of beneficial innovative products to the marketplace.

Michigan Medical Device Association
P.O. Box 170,
Howell, MI 48843;
fax 517/546-3356; [email protected]
Promotes and strengthens the medical device industry in Michigan. It sponsors training seminars and a luncheon speaker series; is active in the areas of government relations, networking, and business development; and acts as a clearinghouse of information of interest to members.

The Motor and Motion Association (SMMA)
P.O. Box P182,
South Dartmouth, MA 02748;
fax 508/979-5845; [email protected]
A North American association with a global focus for electric motors, their control, and application. It serves as the principal voice of the industry and provides a forum to develop, collect, and disseminate technical and management knowledge. Membership includes manufacturers of motors, controls, materials, and components; media; universities; and consultants. SMMA offers motor and control design and application.

National Association of Certified Valuation Analysts (NACVA)
1111 Brickyard Rd., Ste. 200,
Salt Lake City, UT 84106;
fax 801/486-7500; [email protected]
Educates business evaluators about emerging regulations, trends, and other issues that affect the value of healthcare practice groups. The organization has a newly formed Healthcare Practice Group (HPG).

National Association of Manufacturers
1331 Pennsylvania Ave. N.W., Ste. 600, North Tower,
Washington, DC 20004;
fax 202/637-3182; [email protected]
The oldest and largest broad-based association of manufacturers, with more than 14,000 member companies.

National Electrical Manufacturers Association (NEMA), Diagnostic, Imaging, and Therapy Systems Div.
1300 N. 17th St., Ste. 1752,
Rosslyn, VA 22209;
fax 703/841-5900
Through its Diagnostic, Imaging, and Therapy Systems Division, the association lobbies and gathers information for manufacturers of medical imaging and therapy equipment. The division is divided into several groups (nuclear medicine, x-ray equipment, magnetic resonance imaging, ultrasound, radiation therapy, and medical
imaging informatics) to provide detailed information on technological, business, and legislative developments.

National Fluid Power Association
3333 N. Mayfair Rd., Ste. 211,
Milwaukee, WI 53222;
fax 414/778-3361; [email protected]
A trade association of U.S. and multinational manufacturers of hydraulic and pneumatic products and systems.

Neurotechnology Industry Organization
315 30th St.,
San Francisco, CA 94131;
fax 415/358-5888; [email protected]
An organization devoted to informing the media about the neurotechnology industry's progress and contributions to quality of life, advocating the industry's position to regulators and elected officials, and providing effective business development services to members. Members include organizations that research, develop, manufacture, and market biologics, medical devices, and diagnostic and surgical equipment for the treatment of neuro-
logical diseases, nervous systems ailments, and psychiatric illnesses.

New Mexico Biotechnology & Biomedical Association
P.O. Box 80233,
Albuquerque, NM 87198;
fax 505/213-0007; [email protected]
Fosters and promotes the bioscience industry of New Mexico by providing state-based companies, research organizations, and educational institutions with industry connections, exposure, and advocacy at local, state, and national levels.

Packaging Machinery Manufacturers Institute (PMMI)
4350 N. Fairfax Dr., Ste. 600,
Arlington, VA 22203;
fax 703/243-8556; [email protected]
A national trade association whose more than 500 members manufacture packaging and packaging-related converting machinery in the United States and Canada.

Parenteral Drug Association (PDA)
Bethesda Towers, 4350 E. West Hwy., Ste. 150,
Bethesda, MD 20814;
fax 301/986-1093; [email protected]
A nonprofit international association of more than 10,500 scientists involved in the development, manufacture, quality control, and regulation of pharmaceuticals and related products. The mission of the association is education and information sharing in practical applications of pharmaceutical technology. In addition to educational conferences and hands-on laboratory courses, the association publishes technical reports, a scientific journal, and a newsletter on industry and regulatory news.

Radiological Society of North America (RSNA)
820 Jorie Blvd.,
Oak Brook, IL 60523;
fax 630/571-7837
An association of 35,000 radiologists and physicists in medicine dedicated to education in the science of radiology.

Regulatory Affairs Professionals Society (RAPS)
5635 Fishers Ln., Ste. 550,
Rockville, MD 20852;
fax 301/770-2924; [email protected]
An international organization of regulatory professionals. Founded in 1976, the society has grown to nearly 12,000 members worldwide, serving individuals in the pharmaceutical, medical device, biologic, biotechnology, and related areas. The society's goals are to facilitate the exchange of ideas, to foster cooperation among regulatory professionals in industry and government, and to provide continuing education in regulatory affairs.

Society for Biomaterials
15000 Commerce Pky., Ste. C,
Mt. Laurel, NJ 08054;
fax 856/439-0525; [email protected]
A professional society that promotes advances in biomedical materials research and development through cooperative research, educational programs, clinical applications, and professional standards in the biomaterials field.

Society for the Advancement of Material and Process Engineering (SAMPE)
1161 Park View Dr., Ste. 200,
Covina, CA 91724;
fax 626/332-8929; [email protected]
An international professional member society that provides information on materials and processing technology via technical forums, journal publications, and books. The society provides a forum for scientists, engineers, and academicians to exchange ideas and air views.

Society of Manufacturing Engineers (SME)
One SME Dr., P.O. Box 930,
Dearborn, MI 48121;
fax 313/425-3400; [email protected]
A professional society serving the manufacturing industry. Through its publications, expositions, professional development resources, and member programs, SME influences more than 500,000 manufacturing executives, managers, and engineers. Founded in 1932, SME has some 60,000 members in 70 countries and supports a network of hundreds of chapters.

Society of Plastics Engineers (SPE)
14 Fairfield Dr., P.O. Box 403,
Brookfield, CT 06804;
fax 203/775-8490; [email protected]
Helps plastics professionals attain higher professional status through increased scientific, engineering, and technical knowledge. The society has more than 23,000 members worldwide involved in engineering, design, production and processing, research and development, consulting, marketing and sales, purchasing, education, and all levels of management.

Society of the Plastics Industry Inc. (SPI)
1667 K St. N.W., Ste. 1000,
Washington, DC 20006;
fax 202/296-7005; [email protected]
A trade association representing one of the largest manufacturing industries in the United States. SPI's members represent the entire plastics industry supply chain, including processors, machinery and equipment manufacturers, and raw-material suppliers.

Surfaces in Biomaterials Foundation
1000 Westgate Dr., Ste. 252,
St. Paul, MN 55114
fax 651/290-2266; [email protected]
Brings together those who share the common goal of participating in the future of surface biomaterials research. The foundation exists to ensure sponsorship of workshops and symposia, further the exchange of ideas within the surface science and biomedical communities, help in understanding of interfacial problems, and provide a forum that allows interaction and dissemination of information.

U.S.-ASEAN Council
1101 17th St. N.W., Ste. 411, Washington, DC 20036; 202/289-1911, fax 202/289-0519; [email protected]
A national membership organization representing private-sector interests in ASEAN (the Association of Southeast Asian Nations—Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam). The council and its corporate members promote U.S.-ASEAN trade and investment and implement programs that assist U.S. and ASEAN companies in identifying commercial opportunities.

Ultrasonic Industry Association Inc. (UIA)
P.O. Box 2307,
Dayton, OH 45401-2307;
937/586-3725, fax 937/586-3699; [email protected]
Provides access to educators, researchers, users, engineers, products, and applications. UIA's mission is to change the world of medicine and industry through the use of ultrasonics. Membership benefits include discounted registration to symposia, subscription to UIA's Vibration newsletter, and information on applications as well as equipment and service sources.

Underwriters Laboratories Inc. (UL)
333 Pfingsten Rd., Northbrook, IL 60062;
847/272-8800, fax 847/272-8129; [email protected]
An independent, not-for-profit safety testing and certification organization established in 1894. UL evaluates and certifies products, materials, and systems to various safety standards. Services include UL marking for the United States and Canada, notified body assessment of compliance with EU directives, CE marking for medical and IVD devices, FDA 510(k) third-party review, EMC testing, and quality system certification to ISO 9000, EN 13485, and ISO 46000.

Utah Technology Council
2855 E. Cottonwood Pky., Ste. 110, Salt Lake City, UT 84121; 801/568-3500, fax 801/568-1072; [email protected]
A nonprofit organization created to accommodate the needs of businesses and organizations in several industry sectors, including the biotechnology, medical device, diagnostic, and healthcare sectors. Its mission is to develop and promote life science industries by bringing members together in partnership to foster education at all levels; facilitate innovation, excellence, and international competitiveness in products and services; gain consensus for action; and handle matters relating to policy formation, legislation, and regulations.


Agency for Healthcare Research and Quality (AHRQ)
540 Gaither Rd., Ste. 2000,
Rockville, MD 20850;
fax 301/427-1873; [email protected]
Promotes healthcare quality improvement by supporting research that develops and presents scientific evidence regarding all aspects of healthcare. Health services research addresses issues of organization, delivery, financing, utilization, patient and provider behavior, quality, outcomes, effectiveness, and cost. It evaluates the clinical services and the system in which they are provided. It provides information about the cost of care, as well as its effectiveness.

Centers for Medicare and Medicaid Services (CMS)
7500 Security Blvd.,
Baltimore, MD 21244;
fax 410/786-0192
A federal agency within the U.S. Department of Health and Human Services. It oversees Medicare and Medicaid, which serve about 75 million elderly, disabled, and low-income people. CMS is engaged in policy development; program operations; legislative analysis and liaison activities; healthcare research and demonstrations; budget preparation and analysis; actuarial studies, data collection and processing; and enforcement of quality standards.

Environmental Protection Agency (EPA)
Ariel Rios Bldg., 1200 Pennsylvania Ave. N.W.,
Washington, DC 20460;
fax 202/501-1450; [email protected]
Ensures that federal environmental laws are implemented and enforced effectively; that economic development and environmental protection are integrated in U.S. foreign and domestic policy; and that public and private decisions affecting energy, transportation, agriculture, industry, international trade, and natural resources integrate considerations of environmental quality.

Export-Import Bank of the United States
811 Vermont Ave. N.W.,
Washington, DC 20571;
202/565-3946 or 800/565-3946,
fax 202/565-3380; [email protected]
An independent government agency that helps finance the overseas sales of U.S. goods and services. The bank's mission is to create jobs through exports. It guarantees working-capital loans for U.S. exporters and the repayment of loans by foreign purchasers of U.S. goods and services. The agency also offers export credit insurance policies to protect against political and commercial risks of a foreign buyer defaulting on payment.

Federal Trade Commission (FTC)
600 Pennsylvania Ave. N.W.,
Washington, DC 20580;
fax 202/326-3366
Promotes business competition in the United States and polices anticompetitive practices. The commission also works to prevent false advertising of consumer products through the regulation of packaging and labeling, and it is the primary federal agency responsible for enforcing regulations related to online fraud and privacy issues.

International Trade Administration
U.S. Department of Commerce, 1401 Constitution Ave. N.W.,
Washington, DC 20230;
fax 202/482-4473; [email protected]
Works to streamline export controls that are not essential to national security, help U.S. firms receive orders abroad, and improve trade financing opportunities for U.S. firms. This agency's international economic policy has three components: vigorous action in the United States to strengthen its economy and improve competitiveness, an aggressive approach to opening markets abroad, and a strategy for working with U.S. companies to expand into foreign markets.

National Institute of Standards and Technology (NIST)
Public Inquiries Unit, 100 Bureau Dr., Stop 1070,
Gaithersburg, MD 20899-1070;
fax 301/926-1630; [email protected]
An agency of the U.S. Department of Commerce. NIST's primary goal is to promote U.S. economic growth by working with industry to develop and apply technology, measurements, and standards.

Occupational Safety and Health Administration (OSHA)
200 Constitution Ave. N.W.,
Washington, DC 20210;
fax 202/693-1634
Develops and promulgates occupational safety and health standards, develops and issues regulations, conducts investigations and inspections to determine the status of compliance with safety and health standards and regulations. It also issues citations and proposes penalties for noncompliance. OSHA promotes workplace safety and health and engages in training and outreach programs to educate employers and employees.

Occupational Safety and Health Review Commission
1120 20th St. N.W., 9th Fl.,
Washington, DC 20036-3457;
fax 202/606-5050
An independent federal agency that decides contests of citations or penalties resulting from OSHA inspections of the workplace. The commission has established procedures for conducting hearings, receiving evidence, and rendering decisions by its administrative law judges.

U.S. Department of Commerce, Office of Health and Consumer Goods (OHCG)
International Trade Administration, 14th & Constitution Ave., N.W., Rm. 1015,
Washington, DC 20230;
fax 202/482-0975; [email protected]
Promotes exports and increases international competitiveness of the U.S. medical device industry. The organization helps firms promote health products in international markets. Programs include working with industry to develop seminars that promote exports, participating and supporting trade negotiations to increase U.S. exports and international investments abroad, reducing and eliminating regulatory barriers that impede trade, and preparing industry analysis reports.

U.S. Nuclear Regulatory Commission
U.S. Nuclear Regulatory Commission, Office of Public Affairs,
Washington, DC 20555;
fax 301/415-3716
Regulates the civilian use of by-product materials in the United States to protect the public health and safety, the environment, and the common defense and security. The agency reviews and issues licenses for construction and operation of nuclear power plants and other nuclear facilities. It also licenses the possession and use of nuclear materials for research and medical, industrial, and educational purposes.

U.S. Small Business Administration (SBA)
409 Third St. S.W., Washington, DC 20416; 800/827-5722, fax 202/481-5881; [email protected]
Provides new and established small businesses with financial assistance, management counseling, and training. The administration also licenses and regulates small business investment companies. Special programs have been developed by SBA to expand and promote ownership of businesses by women and minorities.


Association of British Healthcare Industries (ABHI)
111 Westminster Bridge Rd., London, UK SE1
7HR; +44 20 79604560, fax +44 20 79604361; [email protected]
The UK trade association for the medical device and systems industries. Members include manufacturers, distributors, and associated service companies.

Place des Maïeurs 2, 1150 Woluwe St. Pierre,
Brussels, Belgium; +32 2 7722212,
fax +32 2 7713909; [email protected]
Trade association representing the medical device industry in Europe. Members include European manufacturers and distributors of medical devices and accessories (excluding IVD devices, active capital equipment, and optical and emergency equipment), plus national device associations in 24 European countries and pan-European product associations.

39/41 rue Louis-Blanc, 92400,
Courbevoie, France;
+33 1 47176388,
fax +33 1 47176389; [email protected]
The medical technology section of the European Federation of Precision, Mechanical, and Optical Industries. SNITEM is also a member of Eucomed.

European Committee for Electrotechnical Standardization (CENELEC)
35 rue de Stassartstraat, B-1050
Brussels, Belgium;
+32 2 5196871,
fax +32 2 5196919; [email protected]
Develops standards in close cooperation with the International Electrotechnical Commission. The members of CENELEC are the National Electrotechnical Committees of 20 European countries. There are 14 affiliate countries.

European Committee for Standardization (CEN)
36 rue de Stassart, B-1050,
Brussels, Belgium;
+32 2 550811,
fax +32 2 5500819; [email protected]
Develops European standards. Membership consists of standards institutions of the European Union and the nations of the European Free Trade Association and the Czech Republic. Standards are adopted by qualified majority voting and must be implemented by the European standards bodies. They are voluntary in application. Many support EU policies.

European Diagnostic Manufacturers Association (EDMA)
Place de Maïeurs No. 2, 1150 Woluwe Saint-Pierre,
Brussels, Belgium;
+32 2 7722225,
fax +32 2 7722329; [email protected]
A nonprofit confederation of diagnostic manufacturers and national associations representing the European IVD industry.

Federation of the European Dental Industry (FIDE)
Aachener Strasse 1053-1055,
Köln, D-50858, Germany;
+49 221 50068723,
fax +49 221 50068721; [email protected]
Founded in 1957, FIDE includes members from Austria, Belgium, Denmark, France, Germany, Italy, The Netherlands, Russia, Spain, Sweden, Switzerland, Turkey, and the UK.

Hexagon Holding APS
Mikkel Bryggers Gade 10, DK-1460,
Copenhagen, Denmark;
+45 33114122,
fax +45 33133859; [email protected]
A professional conference organizer that sponsors two annual European conferences and exhibitions: Pharmaceutical and Medical Packaging in May and Medical Plastics in November.

International Electrotechnical Commission (IEC)
3 rue de Varembe, P.O. Box 131, CH-1211
Geneva 20, Switzerland;
+41 22 9190211,
fax +41 22 9190300; [email protected]
An organization creating international standards for the electrical and electronics industries. IEC has developed a series of standards that enables electromedical equipment to work together no matter where they are designed, manufactured, assembled, or used.

International Organization for Standardization (ISO)
1 chemin de la Voie-Creuse, P.O. Box 56, CH-1211
Geneva 20, Switzerland;
+41 22 7490222,
fax +41 22 7493430; [email protected]
A worldwide federation of national standards bodies from some 150 countries that promotes the development of standardization and related activities to facilitate the international exchange of goods and services and to develop intellectual, scientific, technological, and economic cooperation. ISO's technical committees, working groups, and ad hoc study groups represent the viewpoints of manufacturers, vendors and users, engineering professions, testing laboratories, public services, governments, consumer groups, and research organizations in each member country.

LifeSciences British Columbia
1188 W. Georgia St., Ste. 900,
Vancouver, BC, Canada V6E 4A2;
fax 604/669-9912
Supports and represents the biotechnology, medical device, and greater life sciences community of British Columbia through leadership, advocacy, and promotion of science and industry.

405 The West Mall, Ste. 900,
Toronto, ON, Canada M9C 5J1;
fax 416/620-1595; [email protected]
A nonprofit trade association representing more than 130 manufacturers and distributors of medical technologies in Canada. Medec has action groups focused on regulatory, marketing, professional development; regional and government issues; and sector groups in cardiovascular, diagnostics, orthopedic, ophthalmic, diabetes, and medical imaging. Medec's awareness program, Transforming Health Through Medical Technology, showcases health technologies through the stories of Canadian patients, researchers, physicians, and other healthcare providers.

Medical Technology Association of Australia
Level 12, 54 Miller St.,
North Sydney, New South Wales, Australia 2060;
+61 2 99000650,
fax +61 2 99000655; [email protected]
Represents manufacturers, importers, and distributors of medical devices and medical diagnostic products. The association serves as the Australian link in global regulatory and standards harmonization, and maintains strong ties with its counterparts in North America, Europe, Japan, and New Zealand. It provides education and information on matters that affect the industry and offers networking opportunities to members with common interests. It acts as an industry advocate in regard to technical and regulatory issues and works with government and professional bodies.

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