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.
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.
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.
Attached files:
Template Audit Plan
Template Audit report
Template Audit Programme
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