Quality and regulatory (QA/RA) consultancy for medical device sector

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.