MICHAEL SCHAEFER

Quality Management
Regulatory Affairs
in Medical Devices

 

Training and Templates for Internal Auditing

Since 2015 you may meet me at some TÜV Süd Academies when visiting the 2-days Internal Audit class. As always, you can find the templates for download here.

2015-03-21 21:46:19

Discover MDSAP

The Medical Device Single Audit Program (MDSAP) offers huge opportunities for international Medical Device Companies. Read the informative IMDRF documents and guidance from FDA. Especially the MDSAP Companion document gives an excellent overview of international regulations.

2015-03-21 21:57:47

Authorizations

Since 2015 I am auditing for TUEV Süd Product Service (Lead Auditor MDD EAC14, 15, 17.2, 29.2, ISO13485 and MDSAP). In 09/2019 I was authorized as QMS Lead Auditor for (EU) 2017/745 MDR for MDT2001, 2002, 2003, 2008, MDN1101_1, 1201, 1202, 1203, 1208, 1214, MDS1005_1, 1005_2, 1005_3 and MDS 1011-1014.

2021-02-22 08:19:30

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