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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DATA MANAGEMENT SERVICES

Our team of Data Managers will make sure your data will be well-structured, clean, consistent and in perfect shape to support the claims in your Clinical Study Report.

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Latest news, blogs and events

May 24, 2018

Post-market surveillance under a “522 order”: Why, how and what?

Company X has gained 510k clearance for their new heart valve, and was notified by the Food and Drug Administration (FDA) that post-market surveillance (PMS) is required. Why did they receive it, what is it and what does it mean,...

Starter
Regulatory
Pre Market
June 13, 2018

Five Corners joins Factory CRO

Bilthoven, Netherlands — Factory CRO, a leading global contract research organization (CRO) focused on medical devices and in vitro diagnostics (IVDs), has announced that Five Corners is joining Factory CRO. Five Corners is the premier device CRO in Australia, supporting the...

Starter
Factory
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
19
Sep
Centre de Convencions Internacional de Barcelona, Plaça de Willy Brandt, 11-14, Barcelona, Spain

EUROSPINE 2018

The upcoming 2018 annual EUROSPINE meeting and congress in Barcelona will be the scientific highlight of the year for all spine professionals and experts in Europe and beyond. EUROSPINE 2018 will provide a very attractive programme which will allow all...

Meetings & Seminars
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