MDR Effects on Medical Device Processing

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Select one or more of the following webcasts and complete registration. Click any webcast listing to view its details.
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

Overview

Title: Day 3: MDR Effects on Medical Device Processing

Date: Thursday, August 22, 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 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.

Emily Mitzel
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.

Alpa Patel, B.S., RM (NRCM)
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