Medical Device School: How to audit your Suppliers?
A supplier audit is a difficult task that really needs to be well understood. With the new Medical Device Regulation EU MDR 2017/745, there is a specific requirement that Medical Device Manufacturers should have better control of their suppliers.
I always hear that as soon as the supplier is ISO 13485 it is sufficient for the manufacturers, but this is not really answering the question if your product is manufacturers following your specification…
So I propose to more focus on product specification instead of ISO 13485 requirements. Check the discussion I have with Stefan Bolleininger from Be-on-Quality
Who is Stefan Bolleininger?
Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe. He founded the be-on-Quality GmbH consulting agency to passionately support manufacturers during CE approvals or FDA approvals. This support covers the full chain of quality and regulatory requirements: Implementation, maintenance, audits, assessments, and inspections. In the area of “Risk Management and Usability for Medical Devices and Medical Networks”, he holds a teaching assignment at the Technical University of Nuremberg and the VDI Technical Committee “Quality Assurance for Software in Medical Devices”.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses.
Links from the Video
- Stefan Bolleininger LinkedIn: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
- Using audits to improve supplier performance: https://www.mddionline.com/using-audits-improve-supplier-performance