Full Service Medical Device CRO

Factory CRO offers the top services for consultancy, regulatory,
and clinical trial services as well as data management and
statistics.

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Global Coverage

We are counted on for swift and reliable clinical medical
device/IVD services by companies and clients from every
corner of the globe.

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Questions?

We look forward to answering your questions and
helping you with the development of your device.

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REGULATORY SERVICES

Our deep understanding of U.S. and European regulatory agencies ensures your study is designed to meet all pre- and post-market approval requirements. We can assist you with regulatory submissions and study progress reporting.

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CLINICAL TRIAL SERVICES

Our clinical team has extensive experience and knowledge in the clinical trial field, including monitoring & source document verification, trial document handling, and site visits (pre-study, initiation & close out).

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MEDICAL WRITING SERVICES

Factory’s expert team of medical writers can support you in various ways, including clinical study design, protocol development, clinical evaluation, reporting of study results, and Investigator’s Brochure writing.

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Latest news, blogs and events

February 27, 2018

One Medical Device Trial Fits All! ISO 14155 as a Standard for Your Foreign Data Submitted to the FDA

There is interesting news in the medical device world that may impact your clinical strategy! On February 21, 2018, the FDA released its final ruling on the acceptance of data from clinical investigations for medical devices. With this amendment to...

Starter
Regulatory
Pre Market
March 21, 2018

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...

Starter
Regulatory
Pre Market
February 8, 2018

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...

Starter
Regulatory
Pre Market
26
Sep
Studio Tbd, 1070 Myra Ave, Los Angeles, CA 90029, USA

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

NASS 2018 will feature the latest advancements in clinical management, the best researches carried out on respiratory diseases, symposia and workshops for the attendees. Sessions on clinical cases chaired by specialists will be there to understand various subject areas of...

Meetings & Seminars
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Welmoed Gjaltema

I like the dynamics, everyday is different. One day you’ll be at the office, another day you’re on site meeting new, different people.

Meet the team