Factory-CRO is a full service European Contract Research Organization specializing in medical device trials for more than twenty years. Factory-CRO has experience in biological studies and device-drug combination. Factory-CRO is able to go into the field to provide in-person technical training for Investigators on the application of a medical device.
SPEED
In Europe, regulatory approval can normally be received within 8 – 10 weeks
Factory-CRO has an extensive network of clinical, surgical and regulatory professionals
Their executives and staff work side by side with surgeons across Europe, to assure you the right contacts, the best local knowledge, and the fastest clinical start-up
QUALITY
Factory-CRO was the first CRO in Europe to hold an ISO-9001 quality certificate
Strict compliance with ISO-14155, the Medical Device Directives; CPMP/135/95; 21 CFR part 11; and all other applicable medical device regulatory requirements
EXPERTISE
Dr. Dirk Meijer and Dr. Joris Bannenberg, founders of Factory-CRO, are both medical doctors with a PhD in surgical techniques
Factory-CRO is known for both therapeutic expertise and full life cycle support for medical device developers
