Medical Device project B.V.
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.
Depending on your needs we can act at different process levels in your organization e.g. project management for the design and development of medical devices, set up/writing and maintenance Design History File (DHF), product risk management, coordination of pre-clinical safety evaluation, scientific writing (e.g. biological safety overall summary report, literature review), 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 authorities, set-up/implementation and maintenance of Quality Management Systems (QMS), coordinating management review meeting, providing trainings and QMS auditing.