Full Service Medical Device CRO

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

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

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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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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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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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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

January 24, 2019

‘Overseas’ inspections of medical device firms by the FDA: Are you on FDA’s hit-list?

In a recent ‘FDA in Brief ’ report, the agency highlights how more inspections of medical device manufacturers and a targeted risk-based approach have led to improved compliance. In recent years the FDA has taken forceful action to increase its...

Pre Market
February 13, 2019

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...

Pre Market
January 7, 2019

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...

Pre Market
January 9, 2019

Peace for our time? Will medical device trials remain the same after a no-deal Brexit?

The UK Government, more precisely the MHRA, had a productive start of the new year 2019 with a new guidance for medical device trials in the UK in case there is a Brexit with no-deal (published on the 3rd January...

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

Essentials on Lifecycle Management under the EU MDR

As you should know, the Medical Device Regulation (MDR) will be fully implemented in 2020. To inform you about the fundamentals of lifecycle management under the MDR, we would like to invite you to our one-day training course ‘Essentials 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