I’m a consultant in medical device design, quality and regulation. I have experience in the product and process design of active medical device development and maintenance.
My professional career started in 1998 and within healthcare since 2008. I have a practicable result-oriented way-of-working, well analytical skills and a I can flexibly cope with changing situations. My educational backgrounds are in software engineering, communication and business administration.
Worn many hats in my career as computer programmer in a vast amount of languages and environments, application manager, project lead, information-analyst, process-analyst, quality assurance officer and consultant.
My fascination is to create and implement innovative, yet lean, quality management systems with focus on -agile- product development processes. And to help setting up regulatory strategies, technical files, and other pre and post market regulatory activities in the medical device domain.
I’m experienced in the:
US FDA (QSR, 510(k))
EU (MDD, AIMDD) medical device regulations
Both applied in implementation of quality management systems, upfront regulatory strategies and product submissions.
Other areas of expertise are:
Application life cycle management,
Information security (ISO 27001, NEN 7510)
Design reliability practices (including Design for Six Sigma).
A detailed curriculum vitae will be provided upon request.