Webinar

Free Webinar | The essence of MDSAP++ country-specific QMS demands - What is it all about and lessons learned

September 22, 2022

Date: 22 September 2022

Time: 16:00h - 17:00h CEST | 10:00-11:00 am EST

Location: Virtual

Language: English

Introdution

Nearly every jurisdiction around the world has a formalized registration process that medical device manufacturers must follow to legally sell a product into markets. Some of them may differ slightly from the next. Not only do manufacturers need to register their device(s) initially, but they may need to renew their registration on a recurring, annual basis and support the device post-market. Leveraging an industry-specific Quality Management System (QMS), which is built to enable those processes, is key to success. At the end of the day, one of the main purposes of the QMS is to bring together regulatory requirements from a variety of jurisdictions into a single systematic approach that allows the organization to conform to these differentiating requirements. This is not only about successful device registration!

This webinar learns you to understand the additional jurisdictional specific QMS requirements for some major/emerging markets such as Taiwan, South Korea, and China and provides insights in our practical experience from internal and mock audits.

Trainers:

Olena Hoi, MSc
Henk-Willem Mutsaers
Post date: July 05, 2022
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