factim medical product creation

Over factim medical product creation

factim medical product creation

ABOUT

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, we manage medical device development projects from initial concept to product certification.

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

Adres

• Hoofdkantoor

  Bosweg7241JH LochemGelderland, Nederland

Team per functiegebied

Gebaseerd op 1 openbare functieprofielen, stand van 4 september 2026.

• Consulting / Advisory1