MDMA Member-Only Webinar: Harmonization of 21CFR 820 (QSR) and ISO 13485
Tell a Friend About This EventTell a Friend
MDMA Member-Only Webinar: Harmonization of 21CFR 820 (QSR) and ISO 13485

4/24/2019
When: April 24, 2019
2pm - 3pm ET
Where: United States
Contact: Sheri DeVinney
202-354-7171

« Go to Upcoming Event List  

 

On Wednesday, April 24th at 2pm ET, MDMA will host a Member-Only (no cost)webinar, “Harmonization of 21CFR 820 (QSR) and ISO 13485”, presented by E.M.M.A. International Consulting Group.

Another step taken by the FDA to harmonize with the international standards after its participation in the Medical Device Single Audit program is to further align 21CFR Part 820 with ISO 13485. The FDA’s QSR is based on fundamentals in ISO 9001 as well as ISO 13485; however, it has never been revised since its release in 1996. The purpose of this webinar is to explore how this change will impact small to large med device manufacturers including the business impact that it may have.

 

You must be logged in to register.  If you have any problems, please contact Sheri DeVinney at sdevinney@medicaldevices.org.