MICHAEL SCHAEFER
Auditing
Auditing
As a freelancer I offer onsite and remote audits of your organization. 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. Together, we can tailor the audit plan to your needs.
Notified body audits
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).
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. If MDSAP will be new to your organization, a mock inspection ahead of the initial certification may be useful.
Templates for internal auditing
As always, you can find some templates for download here:
Address
Heiligkreuzstrasse 59,
72379 Hechingen Germany