Jamel Kwakernaak

Began career in medical device engineering at Philips, then shifted to regulatory affairs after completing a master's in health law at Leiden University. Managed EU MDR compliance documentation for cardiac monitoring devices across European markets. Developed internal training programs on risk management principles aligned with ISO 14971 standards. Currently oversees cross-functional teams ensuring product safety documentation meets Dutch and EU requirements. Motivated to write about the practical challenges of implementing regulatory standards in fast-paced development cycles. Focuses on how quality management systems adapt to evolving healthcare technologies. Interested in sharing lessons learned from navigating post-market surveillance obligations for digital health products.