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.
My fields of expertise are in:
– 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).