Satisfying ISO 18562 and FDA Biocompatibility Regulatory Requirements for Breathing Gas Pathways in Healthcare Application

In March of 2017, the new ISO 18562 standard series was released. This standard covers the general principles regarding biocompatibility assessment of medical device materials which comprise the gas pathway. This standard greatly increases the scrutiny for gas path devices and their required tests. This presentation will cover the required biological endpoints and the unique test methods to test these devices.

Tues, February 20, 2018 (all day)

Duration: 45 minutes

Sponsored by: Nelson Labs

automating policy management: document control, training and exception handling

a dynamic policy management system is critical to an organization’s grc initiatives. increased litigation, compliance requirements and a diverse workforce require a well-constructed policy management system to mitigate risk and improve user compliance. learn how automating and integrating policy management creates a controlled process to design, communicate and track corporate policy and procedure. the presenter will discuss policy challenges and solutions, including development, review and release, attestation and training, revision management and exception handling.

tues, january 23, 2018 (all day)

duration: 28 minutes

sponsored by: asssurx

packaging: design for sterilization

medical device packaging plays a critical role in the efficacy and safety of the device being packaged. each device will have its own unique requirements for sterilization and the packaging design must support this role. each sterilization method, eo, steam, gamma and so on presents unique challenges to the packaging design engineer. armed with a few resources, knowledge of the sterilization method, and with some careful planning, the packaging design engineer will be able to successfully bring the medical device from concept to end user in a safe usable condition.

thurs, dec 7, 2017 (all day)

duration: 40 minutes

sponsored by: nelson laborartories llc

materials for medical

plastic materials are used with increasing frequency in the medical/healthcare market.  keeping up with the various requirements needed to service this industry is daunting, as the rules are in a constant state of change.  this webinar is designed to highlight the key characteristics of materials used for medical/healthcare applications and manufacturability considerations. 

wed, dec 5, 2017 (all day) - wed, dec 5, 2018 (all day)

duration: 30 minutes

sponsored by: xcentric mold

the “new” eu medical device regulations: a game changer for european medical device companies?

after years of speculation, discussion and debate, the new medical device regulation (“new mdr”) and corresponding in vitro diagnostic regulation (ivdr) were published in may 2017.

this 3-part webinar series will provide an overview of the new mdr focusing on the thinking that lead to them and the thinking to prepare for them. similarities and differences compared to us regulatory and quality requirements will also be discussed emphasizing the actions that attendees should take now to be ready for 2020 and beyond.

tues, december 12 - thurs, december 14 - 02:00 pm each day

duration: 60 minutes

sponsored by: etq

turning user needs into design inputs for medical devices

with consumers today accustomed to having sleek, user-friendly technology at their fingertips, it’s increasingly important for medical technology to meet the same standards for usability and exceptional user experiences. as such, medical device designers today need a deep understanding of user needs and how to translate them into user-centered attributes in the finished device, but gaining those insights can be tricky. join carolyn rose and craig scherer of the medtech design and development firm insight product development for advice on how to uncover user needs and turn them into design inputs for your next innovative medical device.

thurs, dec 14, 2017 - 2:00 pm

duration: 60 minutes

jumpstart your career in medtech

medtech is a great industry in which to stake out a career, with salaries far above the national average for all occupations and high demand for skilled employees. but that doesn’t mean medtech professionals can put their careers in cruise control. to maximize your earning potential and keep the promotions coming, you need to be proactive.  whether you’re looking to move your career forward or get your foot in the door at a medical device or diagnostics company, we’ll have tips and tricks to help you get ahead in our upcoming webinar

tues, nov 14, 2017 - 02:00 pm 

duration: 60 minutes

new fda expectations for endotoxin testing

new fda guidance documents changes the requirements for bacterial endotoxin testing of medical devices. this webinar will cover the four key points that need to be addressed when submitting a (510(k)). information will also be presented on the test methods, endotoxin limits, and sampling plans.

thurs, oct 26, 2017 (all day)

duration: 15 minutes

sponsored by: nelson laborartories llc

improving compliance with increased global regulations

today’s medical device companies must deal with increased product complexity and evolving global regulations. to deliver cutting-edge solutions, companies must comply with quality management system requirements like iso 13485:2016, while meeting corporate and production objectives. medical device companies strive to improve patients’ lives by leveraging the latestquality management systems (qms) to deliver innovative solutions to market while maintaining compliance with the fda and iso regulations. using outdated document-centric qms solutions hinders product development, quality, and production processes. how can you improve compliance and performance?

wed, oct 4, 2017 - 02:00 pm

duration: 60 minutes

sponsored by: arena solutions

medical device and pharmaceutical testing regulatory updates, trends, and anticipated changes including: fda, iso, usp, and mdrs

this three-day webinar will provide engineers and qa/qc/ra managers with an overview of medical device and pharmaceutical industry trends, updates, and anticipated changes. four major topics will be covered in three days, including: biocompatibility assessments, sterilization methodologies, packaging integrity testing, and medical device cleanliness testing.

learn the most up-to-date information about these topics from the nelson labs’ experts who sit on the domestic and international committees that set the standards for the industry. these experts understand the day-to-day regulations that impact manufacturers and will be providing relevant, current information for attendees. come prepared with questions, as ample time for your questions will be provided at the end of each webinar.

tues, september 26 - thurs, september 28 - 02:00 pm each day

duration: 60 minutes

sponsored by: nelson laboratories

ic-disc basics. tax benefits for us based exporters

this webinar an introductory overview of the elements of an interest charge domestic international sales corporation (ic-disc) and a discussion of the profile of companies who might benefit from such a structure.

wed sep 6, 2017 (all day)

duration: 30 minutes

sponsored by: sil-pro

how to keep pace with change in med-tech: industry challenges and manufacturing solutions

find out how the medical device market can be prepared to innovate faster and more efficiently through the use of closed-loop manufacturing processes. see how siemens helps you to cope with this increased rate of innovation, to manage product changes as a set of data instead of documents.learn how your peers have succeeded in this changing environment by focusing on improved product outcomes while simultaneously supporting shorter innovation cycles. see how they employ closed-loop integrated systems that allow for real-time decision-making, based on real intelligence.

tue, jul 18, 2017 - 02:00 pm - wed, jul 18, 2018 - 03:00 pm

duration: 60 minutes

sponsored by: siemens plm software

what you need to know about establishing a udi system

are you ready to embrace a udi system? this webinar is perfect for you if you're a medical device manufacturer or health care distributor. your company’s success depends on meeting the challenging demands of your industry. such challenges include regulatory compliances, strict quality assurance requirements, short product life cycles, and multiple subcontractors.

wed, jun 7, 2017 (all day) - thu, jun 7, 2018 (all day)

sponsored by: southeast computer solutions

medical device disinfection for reprocessing products for us and eu

this webinar is designed for engineers, quality assurance personnel, microbiologists, and marketers of reusable medical device manufacturers to deepen their knowledge about disinfection validation methods for reprocessed devices. specifically, attendees will better understand disinfection validation standards and practices in the united states and europe: us fda guidance from 2015, aami tir12, aami tir30, iso15883, among others. validation techniques and information regarding chemical, thermal, and a0 disinfection testing will be explained.

thu, jun 1, 2017 (all day)

duration: 15-minutes

sponsored by: nelson laboratories

drowning in big data: extracting medical device quality and safety insights

there’s a daunting amount of data out there about medical device quality and safety. public sources such as fda and private databases house valuable information about adverse events, recalls, inspection findings and warning letters. but this data can be difficult to locate, standardize and compare. we’ll examine the available safety and quality data sources, what they can tell us, challenges with analyzing the data and what you can do to overcome these challenges.

wed, apr 12, 2017 (all day) - thu, apr 12, 2018 (all day)

duration: 60 minutes

sponsored by: lexisnexis

quality with confidence – what you need to know about digital microscopes for medical device quality processes

this webinar from leica will clear up common misconceptions about digital magnification, resolution and megapixels, and explain why optics in digital microscopes are still the key driver in achieving reliable results in your inspections. our product and application experts will tell you what you really need to know about imaging performance parameters so that you'll be able to make the right decisions when selecting a digital microscope for you specific application.

tue, apr 4, 2017 (all day) - wed, apr 4, 2018 (all day)

duration: 60 minutes

sponsored by: leica microsystems

considerations for third-party reprocessing of single-use medical devices

reusing single-use devices that have been safely reprocessed by a third-party reprocessor can enable healthcare providers to maintain high-quality patient care while saving on costs and reducing medical waste. this webinar will navigate through the required validation aspects to reprocess single-use devices safely and effectively.

thu, mar 30, 2017 (all day) - sat, mar 30, 2019 (all day)

duration: 20-minutes

sponsored by: nelson laboratories

risk management for medical device manufacturers

the three day course – on risk management is an important and challenging topic for all medical device manufacturers. but what is risk and how do we manage it? there are many connotations of risk and many methods used to manage them. although there are "industry standards" such as iso14971 and others, risk remains a source of confusion for manufacturers and regulators alike. during this 3-part interactive webinar, a more systematic, engineering-minded approach to risk is presented using multiple examples of medical devices to demonstrate important concepts. ultimately risk is not a simple matter! following the webinar, participants will have a much better appreciation of the importance of risk and how to manage it.

tue, mar 28, 2017 (all day) - wed, mar 28, 2018 (all day)

duration: 60 minutes per day

sponsored by: etq

3 steps for designing the ideal medical device packaging system

cleancut technologies will present 3 important steps to consider when designing your ideal medical device packaging system, including why it is critical to plan early, the importance of properly sized packaging, and utilizing a robust testing protocol. if you are part of a design or new product team, you’ll want to join us for this informational webinar!

wed, mar 1, 2017 (all day)

duration: 15-minutes

sponsored by: cleancut technologies, llc

reducing device cost with innovative medical materials

polycarbonate and pet are well-known materials to medical device material specifiers and has been used for decades. in many applications, polycarbonate and pet are more highly engineered resins compared to actual application needs. innovations in medical materials have produced viable alternatives to polycarbonate and pet in applications where high impact, chemical and heat resistance are not needed. this webinar is designed to educate engineers, product managers and material specifiers charged with reducing medical device costs and who are interested in considering new materials which may be more appropriate for their design goals.

wed, feb 15, 2017 (all day)

duration: 30-minutes

sponsored by: entec polymer

the power of extractable/leachable chemistry testing for medical devices

this presentation will teach you the three most important points of extractable/leachable chemistry testing for medical devices: how it will save you time and money, how it provides detailed information that protects patient safety, and how it will keep you at the front of an evolving approach to the evaluation of biocompatibility.

thu, dec 8, 2016 (all day)

duration: 35-minutes

sponsored by: nelson laboratories

changing a colorant in an approved medical device, what should i know?

in this webinar we will examine the unique challenges colorants pose to medical devices, including fda's current position on changing a colorant or pigment. the webinar will cover topics such as possible impacts to human health, how testing can mitigate risk to patient, toxicological risk assessment and choices available for chemical analysis.

thu, oct 27, 2016 (all day)

duration: 30-minutes

sponsored by: nelson laboratories

how to develop a risk based biological safety evaluation per new us fda guidance

this three day course will incorporate the new us fda guidance on biocompatibility into the three main steps in developing a biological safety evaluation (bse): biological evaluation plan (bep), testing options, and biological evaluation report (ber). composed of three one-hour presentations followed by q&a sessions, the course will cover each step in developing a bse in detail. this course will provide insight into regulatory expectations when it comes to evaluating device safety.

tue, aug 30, 2016 - 02:00 pm - thu, sep 1, 2016 - 03:00 pm

duration: 60-mins per day

sponsored by: nelson laboratories

when do i really need to perform an ethylene oxide requalification?

one of the first questions that comes to mind after completing an eo sterilization qualification is, "when do i need to perform a requalification study, and what will that study entail?" maintaining the validated state of a sterilization cycle and ensuring the process consistently and continually delivers the desired sal is of utmost importance. this presentation takes a comprehensive look at the typical validation approach, the factors that determine when requalification is necessary, and how the expectations in ansi/aami/iso 11135 have changed in recent years regarding requalification.

thu, jul 21, 2016 (all day)

duration: 30-minutes

sponsored by: nelson laboratories

new approaches to assessing biocompatibility for medical devices

literature research and chemical characterization tests are increasingly becoming alternatives when it comes to reducing biocompatibility testing on animals. in fact, considerable progress is being made in the development and standardization of new in vitro test methods—particularly when it comes to cytotoxicity, sensitization, and irritation, the basic tests performed for any medical device regardless of the device's application. these alternative in vitro methods provide multiple benefits, including a smaller sample amount, less time required to perform the test, and reduced animal use.

thu, may 19, 2016 (all day)

duration: 30-minutes

sponsored by: nelson laboratories