Biocomaptibility and the New MDR

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Day 1: Biocomaptibility and the New MDR

Tuesday, August 20, 2019, 09:00 AM PDT

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

Wednesday, August 21, 2019, 09:00 AM PDT
Day 3: MDR Effects on Medical Device Processing

Thursday, August 22, 2019, 09:00 AM PDT

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Title: Day 1: Biocomaptibility and the New MDR

Date: Tuesday, August 20, 2019

Time: 09:00 AM Pacific Daylight Time

Duration: 1 hour

Summary

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

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.

Sponsored by:
Nelson Labs


Day 1: Biocomaptibility and the New MDR

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.

Thor S. Rollins, B.S., RM (NRCM)
Director, Toxicology and E&L Consulting
Nelson Labs

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 many published articles on biocompatibility topics.

He is a participating member on all Association for Advancement of Medical Instrumentation (AAMI) TC 194 and 10993 ISO committees and plays an active role along with the FDA and regulatory committees developing standards, discussing biocompatibility methods and voting on changes to those standards. As one of a select group of experts in the industry, Thor’s participation on the committees offers him insight on industry changes and helps prepare clients for changes in testing.

Audrey Turley
Technical Consultant
Nelson Labs

Audrey Turley has 22 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 by Nelson Laboratories, which include cytotoxicity (MEM and agar overlay), hemolysis (PTT, PT, complement activation, blood circulation, ASTM and NIH methods), and genotoxicity (Ames and chromosome aberration). Audrey also has experience performing, consulting and training on bioburden, microbial IDs, sterility and BF testing. She trains staff within the biocompatibility department and works on a company-wide live to trouble shoot problems.

Event Information

Event Topic:
Biocomaptibility and the New MDR

Event Description:
Free Webinar but you must pre-register

Date/Time:
Date(s) - 08/20/19
9:00 am

Event Location:
Other:

Event Details

Event Type