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ISO 13485 Registrars List

In 2003, the International Organization for Standardization (ISO) published the ISO 13485 standard, “Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes.” ISO 13485:2003, which is based on ISO 9001:2000, was created to harmonize medical device regulatory requirements for quality management systems. The standard includes several requirements particular to medical devices and omits some of the requirements of ISO 9001. This list provides a sampling of registrars accredited to assess a company’s quality management systems and to issue a certificate confirming that the organization’s quality management system meets the requirements of ISO 13485.

ABS Quality Evaluations Inc.
Contact: Dominic Townsend
16855 Northchase Dr.
Houston, TX 77060
201/287-8353
fax: 201/342-0173
[email protected]

American Management Technology Inc.
Contact: Brian Barch
1106 Kathy Ct.
Fontana, WI 53125
262/275-5468
fax: 262/275-1418
[email protected]

American Systems Registrar (ASR)
Contact: Richelle Kinzie
5281 Clyde Park Ave., S.W.
Wyoming, MI 49509
888/891-9002, 616/942-6273
fax: 616/942-6409
[email protected]

BSI Group America Inc.
Contact: Shereen Abuzobaa
12110 Sunset Hills Rd., Ste. 200
Reston, VA 20190-5852
703/464-1931
fax: 703/437-9001
[email protected]

Bureau Veritas Certification
Contact: Chris Carson
390 Benmar Drive, Ste. 100
Houston, TX 77060
651/423-2162
Fax: 281/310-3101
[email protected]

DEKRA Certification Inc.
Contact: H. Pierre Sallé
4377 County Line Rd.
Chalfont, PA 18914
215/997-4519 ext. 41305
fax: 215/997-3810
[email protected]

Eagle Registrations Inc.
Contact: Brian Payne
123 Webster St., Ste. 300
Dayton, OH 45402
800/795-3641
fax: 937/293-0220
[email protected]

HSB Registration Services
Contact: Janet Kowalski
595 E. Swedesford Rd.
Wayne, PA 19087
484/582-1419
fax: 484/582-1802
[email protected]

Intertek
Contact: Lauren Reidy
70 Codman Hill Rd.
Boxborough, MA 01719
800/810-1195
fax: 978/263-7086
[email protected]

ISOQAR Inc.
Contact: Andy Smith
24840 Burnt Pine Dr., Ste. 5
Bonita Springs, FL 34134
866/947-6727 or 239/947-6980
fax: 239/947-4251
[email protected]

Lloyd’s Register Quality Assurance Inc.
Contact: Kunden Dhillon
1330 Enclave Pky., Ste. 200
Houston, TX 77077
407/384-1257
fax: 407/492-8656
[email protected]

National Quality Assurance USA
Contact: Arlen Chapman
4 Post Office Square
Acton, MA 01720
978/635-9256
fax: 978/263-0785
[email protected]

National Standards Authority of Ireland
Contact: Chris Morrell
402 Amherst St.
Nashua, NH 03063
603/882-4412
fax: 603/882-1985
[email protected]

NSF International Strategic Registrations (NSF-ISR)
Contact: Tony Giles
789 N. Dixboro Rd.
Ann Arbor, MI 48105
734/827-6881
fax: 734/827-7829
[email protected]

Orion Registrar Inc.
Contact: Lori Correia
7850 Vance Dr., Ste. 210
Arvada, CO 80003
303/456-6010
fax: 303/456-6681
[email protected]

Perry Johnson Registrars Inc.
Contact: Terry Boboige
755 W. Big Beaver Rd., Ste. 1340
Troy, MI 48084
800/800-7910
fax: 248/358-0882
[email protected]

SAI Global Certification Services Pty. Ltd.
Contact: Guillaume Gignac
2 Summit Park Dr., Ste. 425
416/401-8653
fax: 416/401-8650
[email protected]

SGS
Contact: Don Castle
Meadows Office Complex
201 Rt. 17 N.
Rutherford, NJ 07070
201/508-3000
fax: 201/508-3191
[email protected]

Smithers Quality Assessments, Inc.
Contact: Drew Markley
425 West Market St.
Akron, OH 44303-2099
330/762-4231 ext. 1440
fax: 330/762-7447
[email protected]

SRI Quality System Registrar
Contact: Christopher Lake
300 Northpointe Circle, Ste. 304
Seven Fields, PA 16046
724/934-9000
fax: 724/935-6825
[email protected]

TÜV Rheinland of North America Inc.
Contact: Brian Ludovico
1300 Massachusetts Ave., Ste. 103
Boxborough, MA 01719
978/266-9500, ext. 234
fax 978/266-9992
[email protected]

TÜV SÜD America Inc.
Contact: Reiner Krumme
1775 Old Hwy. 8 N.W.,
Ste. 104
New Brighton, MN 55112
651/638-0278
fax: 651/638-0285
[email protected]

TUV USA Inc.
Contact: Mike Hopkins
215 Main St., Ste. 3
Salem, NH 03079
603/870-8023
fax: 603/870-8026
[email protected]

UL DQS Inc.
Contact: Richard Burgess
1130 W. Lake Cook Rd., Ste. 340
Buffalo Grove, IL 60089
847-279-3300
fax: 631/439-6022
[email protected]

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