Day 1: Biocomaptibility and the New MDR
Tuesday, August 20, 2019, 09:00 AM PDT
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Day 2: Navigating Packaging changes in light of New Regulatory Requirements
Wednesday, August 21, 2019, 09:00 AM PDT
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Day 3: MDR Effects on Medical Device ProcessingThursday, August 22, 2019, 09:00 AM PDT |
Title: Day 3: MDR Effects on Medical Device Processing
Date: Thursday, August 22, 2019
Time: 09:00 AM Pacific Daylight Time
Duration: 1 hour
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:
Day 3: MDR Effects on Medical Device Processing
The new Medical Devices Regulation (2017/745/EU) (MDR) brings EU legislation into line with technical advances, chang¬es in medical science, and progress in lawmaking. There are many updates that affect reusable medical device manufacturers. This presentation will outline all of the testing and documentation that needs to occur prior to the MDR deadline.

Technical Consulting Manager, Sr. Scientist
Nelson Laboratories, LLC
Emily Mitzel is a Technical Consulting Manager and Senior Scientist at Nelson Laboratories; a microbiological testing company specializing in improving the quality of life by ensuring medical products are safe, sterile, and functional.

Senior Scientist (Healthcare Reprocessing)
Nelson Laboratories, LLC
Alpa Patel is a certified microbiologist and specializes in consults with clients about cleaning/disinfection and sterilization of reusable medical devices, endoscopes and tissue disinfection or validation processes. She actively speaks on cleaning, disinfection, sterilization and tissue process validations.
As a member and collaborator with the American Standard Test Methods (ASTM), American Association of Tissue Banks (AATB) and American Association of Medical Instrumentation (AAMI), she plays an active role, in concert with the FDA and regulatory committees, in developing standards and discussing and voting on changes to those standards. Alpa is one of a select group of experts in the industry, and her participation on these committees offers insight on industry trends and helps prepare Nelson Laboratories and its clients for the most up to date medical device validation requirements.
Event Information
Event Topic:
MDR Effects on Medical Device Processing
Event Description:
Free Webinar but you must pre-register
Date/Time:
Date(s) - 08/22/19
9:00 am - 10:00 am
Event Location:
Other: Free Webinar
Event Details
Event Type