Willem van Den Biggelaar

Willem van den Biggelaar is an experienced professional in the medical device sector, currently serving as the owner of Process Vision BV since 2000, specializing in lean QA/RA consultancy for various clients including start-ups and established companies. In addition to this role, Willem holds positions as QA Manager at both ZEISS Medical Technology and TOPIC Embedded Systems, focusing on high-precision medical robotic solutions and diverse client projects, respectively. Willem also provides training in medical device regulations and quality systems through Mikrocentrum and own endeavors. Previous roles include interim QA Manager at Motek Medical B.V., RA Manager at Eindhoven Medical Robotics, and certified ISO13485/CE lead assessor for DARE!! Services B.V. and DEKRA Product Testing & Certification, demonstrating a robust track record in audits and certifications. With a Master's degree in Electronics from HTS, Willem brings extensive expertise in quality management systems and regulatory compliance within the industry.