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Medical Device Testing Regulatory Updates, Trends and Changes including: FDA, ISO and MDR

August 21, 2019
August 23, 2019

10:00 am

, , , Jennifer Gygi, and Alpa Patel

This three-day webinar will provide engineers and QA/QC/RA managers with an overview of medical device industry trends, updates, and anticipated changes. Three major topics will be covered in three days, including: biocompatibility assessments, 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.

Day 1: Biocompatibility and the New MDR

Presenters: Thor Rollins and Audrey Turley

This presentation will include an overview of biocompatibility in compliance with the new MDR. The key focus will be on highlighting differences on previous approaches for CE marketing and the requirements in the MDR. Guidance will be provided to establish a roadmap to compliance.


Day 2: Navigating Packaging changes in light of New Regulatory Requirements

Presenters: Wendy Mach and Jennifer Gygi

We will look at the new updates to the MDR’s that have driven the ISO 11607 Packaging changes and what that means with the deadline for implementation fast approaching.


Day 3: MDR Effects on Medical Device Processing

Presenters: Emily Mitzel and Alpa Patel

The new Medical Devices Regulation (2017/745/EU) (MDR) brings EU legislation into line with technical advances, changes in medical science, and progress in law making. There are many updates that effect reusable medical device manufacturers. This presentation will outline all of the testing and documentation that needs to occur prior to the MDR deadline.

Thor Rollins

Thor Rollins

Toxicology and E&L Expert

Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs’ external seminars, webinars, and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in 2013 and has published many articles...

Audrey Turley

Audrey Turley

Biocompatibility Expert

Audrey Turley has 20 years of experience working in research, laboratory, and test design functions in the medical device industry. She is a biocompatibility expert having performed all the in vitro tests offered at Nelson Labs, which include cytotoxicity (MEM and agar overlay), hemolysis (PTT, PT, complement activation, blood circulation, ASTM, and NIH methods), and...

Wendy Mach

Wendy Mach

Packaging Expert

Wendy Mach has over 24 years of medical device manufacturing and laboratory experience. She worked in the medical manufacturing environment in Minnesota for seven years, performing ethylene oxide (EO) and gamma radiation sterilization validations. While at the manufacturing site, she also insourced the microbiology tests for sterility assurance and related equipment validation. Wendy also spent...

Emily Mitzel

Emily Mitzel

Reusable Medical Devices Expert

Emily Mitzel is an Expert Advisor and Senior Scientist at Nelson Labs. Her expertise includes reusable device reprocessing validations, newly manufactured device validations, sterilization, and microbiology testing. Emily presents at Nelson Labs’ seminars, tradeshows, ISO, FDA, AAMI, and client facilities across the U.S. and internationally. Emily is an active committee member of many working groups...


Alpa Patel

Senior Scientist

Nelson Labs’ Alpa Patel was recognized by American Society for Testing Materials (ASTM) for her dedicated work as part of the cleanliness task force in the creation of a new standard giving guidance for selecting test soils for medical device validations. The document is scheduled to be released in early 2017.


Jennifer Gygi

Jennifer Gygi has over 25 years of medical device laboratory experience. She has worked in the Microbiology, Bioburden, IDs, and Packaging sections at Nelson Labs. Jennifer has experience with various microbial tests, including microbial limits, plate counts, Biological Indicator population verifications, organism ID tests and bioburden tests. Jennifer has spent the last 15 years working in the Packaging group. As one of the original packaging group members at Nelson Labs, Jennifer was heavily involved in validating all the packaging test methods and equipment and writing the test procedures for the packaging tests performed at Nelson Labs.