Medical Device Project BV
EU, US, Canada.
Medical Device Project B.V. is an independent Consultancy Company active in the areas of medical devices, biotechnology and life science. We have expertise in project management for the design and development of medical devices, set up, writing and maintenance of Technical Dossiers and Design History Files, product and process risk management, scientific writing, validation of processes, quality management system (ISO 13485) implementation, auditing, training & coaching, and coordination of pre-clinical biological safety evaluation.
Areas of regulatory/reimbursement support:
Medical Device regulatory approval in the EU and US, Quality Management Systems, Auditing, Medical device Design Dossiers, Training.