Erich Zanner

Senior Quality Site Leader
GE Healthcare
Erich Zanner is the quality representative for medical device software development in Munich. He led the site through one of the first MDSAP inspections and supports other GE Healthcare sites with it. He developed and maintains the quality management system at the site in Munich. Before his 15 years in QA for the medical devices industry, Erich worked as QA for food producing companies. Erich holds a diploma as engineer from the Technical University of Munich and is a certified Quality Manager and EOQ Quality Auditor.

2:30 PM Preparing for Your MDSAP Audit

Following on from our ‘teaser’ session in 2017, GE Healthcare will be back to give you all of the practical guidance and support you need to plan your MDSAP audit pathway.

With an annual audit that will get your device certified for five key medical device markets – and the incoming Canadian MDSAP audit requirement - the MDSAP program is the future of medical device auditing.
Speaking from personal experience of two MDSAP audits, GE Healthcare will help you become MDSAP audit ready.

- Understand the global reach and company impact of transferring to the MDSAP audit route
- Discover the finer details of the MDSAP from a QA expert, and figure out if it could help you save time and increase compliance
- Plan your MDSAP audit timeline – what do you need to be doing, and when?
- Develop an understanding of the numerous advantages and potential disadvantages of the program, to evaluate its value for your organisation
- Follow on from the 2016 Pilot program and look at the global role-out of the MDSAP audit – make sure your company is not left behind!