EXPERIENCE TO UNDERSTAND EACH PARTY                   

Knowledge and experience

• Over 25 years of knowledge and experience in the medical device industry

• A broad experience regarding Quality Management Systems and EU Market Access/ Conformity Assessment.

Working experience at all parties: 

• In multiple Medical Device Companies (software -, active - and non-active devices) with responsibilites in Quality Assurance and Regulatory Affairs,

• At a Notified Body for CE-marking of medical devices being a lead auditor and technical documentation reviewer,

• As Consultant supporting Medical Device Companies and their Suppliers towards market authorization, quality management systems, auditing and training,

• As Person Responsible for Regulatory Compliance (EU MDR 2017/745) and Management Representative.

For details see LinkedIn profile