Header Artwork
Header Artwork

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

August 21, 2019

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.