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Clinical Investigations – What changes because of the Medical Device Regulation?

  Does the MDR change your Clinical Investigations? April 5th 2017 was a historical moment for the medical device industry: the Medical Device Regulation (MDR) was adopted by the European Union. Beginning May 27th, 2020, after a 3 year transition period, this regulation will be the gold standard for the medical device industry. The big question is: how will this influence the conduct of clinical investigations with medical devices? Here, we will guide you through the most important changes from the current regulations. What current standards are amended or replaced...

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Meetings and seminars

Tuesday, Apr 3, 2018

Meadowlands Exposition Center, Plaza Drive, Secaucus, NJ, USA

MDTX (Medical Device Technology Exchange) 2018 Conference & Exhibition in Secaucus

Wednesday, Sep 26, 2018

Studio Tbd, 1070 Myra Ave, Los Angeles, CA 90029, USA

NASS (North American Spine society) 2018 conference in Los Angeles

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Latest news

Earn and Keep Your Market Share Through Reimbursement Support

Market adoption of new medical devices in the United States is largely dependent on the availability of an applicable CPT® code for use in reporting the services provided. Additionally, the existence of positive insurance medical policies outlining coverage for a...

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Start Sooner, Run Fast, Finish Faster – The New York Marathon 2017

At Factory CRO we believe that physical fitness stimulates people to get the best out of themselves. Besides the positive energy, it increases company engagement and team spirit. In light of this philosophy, 12 Factory CRO runners successfully completed the...

Pre Market

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.