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

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
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
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
25
May
Aachen, Uniklinik, RWTH, Aachen, Germany

Biomedical Engineering Workshop RWTH Aachen University Hospital 25-26 May 2018

On the 25 and 26th of May 2018 the Biomedical Engineering Master's Program of RWTH Aachen is organizing a biomedical engineering workshop in Aachen in Germany. During this 2-day event the latest knowledge in the field of biomedical engineering and...

Meetings & Seminars
30
May
Hall 8, Fira Gran Via, Carrer de l'Alumini, Barcelona, Spain

19th EFORT Congress 2018 Barcelona

The European Federation of National Associations of Orthopaedics and Traumatology (EFORT) is the platform organisation linking Europe‘s national orthopaedic associations. Its aims reflect the will of all the participating associations to promote the exchange of scientific knowledge and experience in...

Meetings & Seminars
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Richard Veerman

Factory has created a working environment in which knowledge and experience are shared to accomplish goals and complete projects as a team.

Meet the team