I strongly believe that compliance should be organized in a smart and lean manner: ‘lean compliance’. By implementing the smallest quality system that covers the minimum requirements. By removing all processes that do not add value. And by providing tools that really facilitate your staff.
In my experience, lean compliance not only leads to lower overall compliance costs, but it helps your organization to attract and retain the best staff available.
After completing my master in electrical engineering (TU/e), I worked over 15 years in several (medical) device development and production companies. Initially, I worked as a project manager, and completed many multi disciplinary development projects. In 2004, I became a quality and regulatory consultant. Since then, I arranged several product submissions and facilitated many external audits and FDA inspections. Early 2010, I continued my work in quality and regulatory as an independent consultant.
During these years, I saw many companies stressing with regulations and staff running to fix all non-conformities. I started to see some common structural issues with the way companies ensure compliance and I discovered that principles from lean manufacturing were very useful to improve these processes. These days, this focus on ‘lean compliance’ is now embedded in all my consultancy activities.
Over the past years, my network has grown significantly and includes representatives of notified bodies, as well as specialists for several subjects like hospital hygiene, human factors engineering or medical device software development.
Contact Grey RA today and see if my approach to quality and regulatory matches with your company.