About

Services

•  Project management

•  Write the technical files according to MDR 2017/745

•  Generate product concepts (Sketches / 3DCAD SolidWorks)
•  Generate prototypes towards transfer to manufacturing 

•  Perform the risk management process
•  Support with packaging, labelling, IFU and usability research
•  Activate my network at Dutch UMC’s, QA and RA specialists,
   business developers and engineers

Safe and performant

When developing a medical device, both the technical file and a quality management system must be developed alongside the product itself.
The Medical Device Regulation (EU) 2017/745 defines how this development journey must be documented and how a safe and performant functioning is to be demonstrated.
Demonstrating safety and performance requires the planning and executing of tests in laboratory and in clinical settings.

As an expert generalist with extensive experience in the field and versatile design skills, factim manages medical device development projects from initial concept to product certification.

Marc graduated in Industrial Design from the Delft University of Technology, designing and building a disinfection machine for a anaesthesia ventilator at Physio medical systems.
Since then, Marc has accumulated more than 30 years in experience with product development, having worked at three different design agencies, the PCV-Group, Indes and Agence-DA as well as at the notified body, DEKRA.
From 2011 onwards, Marc has focused exclusively on the medtech SME sector. He has been involved with companies such as U-Needle, Medspray Anesthesia and Resyca, all of which have successfully brought products to the international market.

Through this professional journey, Marc discovered that creating medical devices is what truly motivates him. The field demands perseverance and creativity, and he particularly enjoys developing smart solutions to meet medical needs; helping to reduce pain, shorten recovery times, and minimise complications.

Background