Medical Device Project

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.


MDProject can assist you in writing validation master plans, validation protocols and reports but also provide “hands on” activities regarding these topics.

Design and Development

MDProject has set up a structure to minimize the amount of paper work but fulfill all the regulatory requirements needed for submissions by using the harmonized submission STED format

Training & Coaching

We offer a wide range of trainings and our expert trainers have many years of practical experience in their own particular areas of the Medical Device Industry.

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