Factory was founded in 1988 by Joris Bannenberg MD, PhD and Dirk Meyer MD, PhD, MSc. Both hold a PhD in biomaterials and surgical technology and have over 15 years of experience in medical device studies. In the first years activities consisted mainly of consulting. The first contract research activities date back to 1994.
Factory offers a complete range of services from study design to expert reporting in clinical evaluation of Medical Devices.

We are successful because we combine medical and technical knowledge with quality controlled execution of clinical studies. An extensive network of contacts with surgeons of many different disciplines and with notifying bodies throughout Europe helps you to jump-start your clinical studies in Europe.

We are very keen on the quality performance of our studies. We have ISO9001 certified Standard Operating Procedures that comply with EN540 and ICH-GCP regulations. Our quality system was set up with support from Hanny Vlaskamp (HVQM).

The mission of Factory is:
* to improve the safety and efficacy of medical devices, biomaterials and biologicals by objective testing of the conformity of product properties with predetermined safety requirements
* to guide manufacturers of medical devices, biomaterials and biologicals towards product registration and reimbursement via the most efficient pathway
* to provide advice and facilities for preclinical and clinical research within the relevant standards and guidelines

Factory aims herewith to become market leader in preclinical and clinical research.