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 Audit Approach 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, 35.2, ISO13485 and MDSAP). In 09/2019 I was authorized as QMS Lead Auditor for (EU) 2017/745 MDR for MDT2001, 2002, 2003, 2008, 2011, MDN1101_2, 1201, 1202, 1203, 1208, 1214, MDS1005_1, 1005_2, 1005_3, 1005_7 and more. This includes around 100 audits and 170 onsite audit days (2015-2023).

Auditing

As a freelancer I offer auditing your organizations. This may include internal audits, supplier audits and especially mock inspections. I am qualified for ISO 13485, MDSAP MDD, MDR, FDA 21CFR8xx and ISO 17025.