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

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...

Starter
Factory
Pre Market
February 22, 2019

As of TODAY you can collect clinical device data for your IDE or PMA outside of the USA

A year ago, the FDA published their final rule on the acceptability of medical-device clinical data collected outside of the USA (OUS) to support an IDE or device marketing application (1). Published in February 2018, the effective date of the...

Starter
Factory
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...

Starter
Factory
Pre Market
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...

Starter
Regulatory
Pre Market
14
Mar
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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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