Jeannette van Loon
I work as a consultant for medical device manufacturers and fulfill the function of the Quality/Regulatory Affairs Manager, Project Manager of the Design & Development process or as Expert Member of the D&D project team. I fulfill similar roles at suppliers of e.g. raw material or device component suppliers, contract manufacturers or service providers.
I am holding a Ph.D. degree in biomaterials and wrote a thesis on biocompatibility testing of degradable polymers for medical devices.
At the time the Medical Device Directive 93/42/EC was launched in Europe I was senior standardization consultant at the Dutch Standardization Institute (NEN) and as intermediator between industry, authorities, research and the clinical field responsible for national, European and international standardization processes in the field of medical devices, biological safety evaluation, sterilization evaluation, risk management and quality management systems.
I have been COO at a test- and research laboratory specialized in biocompatibility and biological safety testing of medical devices.
Notified Bodies contract me as external reviewer of technical dossier parts (e.g. biological safety evaluation) or as external QMS auditor.
Depending on your needs I can act at different process levels in your organization e.g.
Medical Device – Design and Development (D&D):
– Project management for the design and development of medical devices
– Set up/writing and maintenance Design History File (DHF)
– Set up/writing/advise in parts of the DHF e.g. product risk management report, coordination of pre-clinical safety evaluation, scientific writing (e.g. biological safety overall summary report, biological safety literature study, clinical evaluation literature study), validation of processes (e.g. production, packaging, shelf life)
– European and international regulatory and strategic planning
– Writing technical documentation and submissions for market approval
– Communication with the Notified body, Authorities
– Providing training, coaching, hands on support
– Due diligence product dossier assessment
Medical Device – Quality Management Systems (QMS)
– Set up and implementation Quality Management Systems according e.g. MDD 93/42/EC, ISO13485:2003, USA QSR, CMDCAS
– Coordinating/advise management review meetings
– Providing training and QMS auditing
– Biological safety evaluation of medical devices.