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As of TODAY you can collect clinical device data for your IDE or PMA outside of the USA

A year ago, the FDA published their final rule on the acceptability of medical-device clinical data collected outside of the USA (OUS) to support an IDE or device marketing application (1). Published in February 2018, the effective date of the rule is February 21st 2019! In other words: as of now you can start using medical-device clinical data from trials conducted outside of the USA for IDEs, PMAs, etc. Of course, there are a few restrictions! The most important of which include the following: The trial has to be conducted...

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Factory CRO and Boston Biomedical Associates Announce Merger

The merger realizes the shared strategic goal of becoming the leading Global Medical Device and Medical Technology Focused CRO January 7, 2019 Bilthoven, Netherlands and Marlborough, United States — Factory-CRO Group, a leading global contract research organization (CRO) focused on medical devices and in vitro diagnostics (IVDs), and Boston Biomedical Associates (BBA) a premier full-service Medical Device/Biotechnology CRO and Consultancy based in the United States announce that they have merged the organizations. The merger further advances the shared strategic vision to become the leading Global Medical Device and Medical Technology...

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Meetings and seminars

Thursday, Mar 14, 2019

Factory CRO for Medical Devices B.V., Professor Bronkhorstlaan, Bilthoven, Nederland

Essentials on Lifecycle Management under the EU MDR

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VIDEO: Factory CRO Group

Medical device company looking to partner with a global CRO but do not want a generic approach to your clinical trial? At Factory-CRO Group we are focused, efficient and flexible and pride ourselves in creating a custom plan for each...

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FREE 30 minutes consultation

You may have questions about the regulatory framework for medical devices or clinical trial requirements or even Factory CRO’s services.