Simplicity in Quality Systems

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