Medical Device Project B.V. (MDProject) is an independent quality and regulatory consultancy company specialized in the medical device field. Since 2008 we assist our clients towards EU and US regulatory approvals of a wide variety of devices used in various clinical fields, ranging from implants, diagnostic equipment to software devices and in vitro diagnostics. MDProject senior consultants have years of work experience at different stakeholders like the legal medical device manufacturer, supplier, the distribution chain, Notified Body and health institutes. We understand the changes a company is facing during growth, from research to start-up, scale-up, merging and business take over. Therefore, we can act as sparring partner to management and help to map out the regulatory strategy, provide sufficient information for decision making relevant to the phase the company is in while aiming compliance to Medical Device Regulations. In parallel, we provide helping hands to individuals or project teams in the organization to get the job done. Main focus of our activities are on the design and development of medical devices, implementing Medical Device Regulations, set up, writing and maintenance of Technical Dossiers, product and process risk management, medical device software development, biological evaluation, usability validation, clinical evaluation, scientific writing, process validation, software validation, quality management system (e.g. ISO 13485) implementation, auditing, training and coaching.
I am an expert QA/RA consultant in Medical Device Regulation and specifically in biological safety evaluation including toxicological assessment. I work for almost 25 years for the medical device industry assisting in the design and development processes of medical devices, building Design History Files, writing Technical Dossier for regulatory approval and the set up of Quality Management Systems. In 2008 I founded Medical Device Project B.V. (MDProject), a QA/RA company specialized in medical devices.
Earlier in my career, I worked as COO at a test and research laboratory specialized in the microbiological and biological safety testing of medical devices. For more than 15 years I have been expert technical dossier reviewer for a Notified Body on the topic biological safety evaluation.
As Medical Biologist I am holding a PhD degree in Biomaterials and wrote my doctoral thesis on “Biocompatibility testing of degradable polymers."