To broaden MD squared’s offering in the field of quality management for Medical Devices Claus Schaffrath passed the BSI exam Lead Auditor ISO 13485:2016 after attending a training of one week in Gent, Belgium.
“When working with my clients on Product Claim Management for their Medical Devices”, Claus Schaffrath, Managing Director at MD squared explained, “the structural setup of strong claims often touches regulatory compliance and requires adequate procedures in the quality management system (QMS) of a Medical Device company. After helping some of my clients to develop a risk based QMS approach, which is at the heart of the ISO 13485 standard in its latest (2016) version, I was curious to understand how auditors would look at the ISO 13485:2016. The one week training by the British Standards Institution (BSI) followed by an exam for Lead Auditor ISO 13485:2016 has helped me to gain the perspective of a Notified Body on the adequate implementation of a quality management system for Medical Devices.”