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

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
September 6, 2018

Risk Based Monitoring – A state of the art approach for your clinical investigation

Factory CRO witnesses and is part of a new trend in the clinical investigation landscape: Risk Based Monitoring (RBM). In this novel approach, focus lies on specific risks related to your clinical investigation, thereby more efficiently using resources, which improves...

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
2
Dec
Kaufmann St 12, Tel Aviv-Yafo, Israel

International Conference for Innovations (ICI) Meeting

The premier International Conference for Innovations in Cardiovascular Systems (Heart, Brain and Peripheral Vessels) and High-Tech Life Science Industry, will be held in Tel Aviv, Israel, December 2-4, 2018. The ICI Meeting is an acclaimed forum which aims to explore fuel, spark...

Meetings & Seminars
17
Dec
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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Niels van Tienen

At Factory we have short communication lines, making communication fast, effective and efficient.

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