MedTech Safety
Bio
Jean Blom is the Quality Manager for Medical Devices at Medace, accountable for the ISO 13485 QMS certification applying to its Maastricht cleanroom facilities. Towards Medace’s startup clients, he provides training, guidance, coaching, and consulting. This focuses on the quality system aspects, including systematizing compliance with regulations, integrating risk management, and performing and undergoing audits.
Before Medace, he worked hands-on in quality and regulatory for a start-up's class IIA Active Diagnostic Medical Device, and as the quality systems-focused officer at a major multinational medical device developer and manufacturer with a large variety of devices and operations in the ophthalmic surgery segment. This provides him with a breadth and depth of experience for Medace's diverse client base that is calibrated on what is to come, brought in a manner which is understandable and practicable.
Perhaps unusual his academic origin is not medical or technical, despite a short stint at Electrical Engineering at the Technical University in Eindhoven. He completed his Bachelor of Science in Econometrics and Operations Research, and got sidetracked into the start-up world during his Master’s on International Business Controlling. This scientific management system focus made him especially suited for working with and on the systems approach implemented through many standards, including ISO 13485 and ISO 14971.
Jean’s work in MedTech is motivated by the principles of safety and effectiveness, and thus builds on the intent of requirements and rules through their subtext and interaction, instead of purely their ‘as-written’ meaning.