Full Service 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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CE marking and FDA submissions

We are well acquainted with CE-marking studies and FDA regulations and can assure that your study can be designed and controlled to meet the demands of Notified Bodies and FDA.



  • Pre-study & initiation visits
  • Monitoring visits
  • Source document verification
  • Close out visits
  • Trial document handling
  • Reporting of safety information
  • Administrative tasks
  • Data Management


Factory’s expert team of medical writers are well-trained in conducting clinical evaluations. We can conduct the clinical evaluation for you, or support you in the clinical evaluation process.


The post-market world of Class I devices - PMS and…

20 Oct 2016

Post-market surveillance (PMS) and post-market clinical follow-up (PMCF) studies are both an integral part of the upcoming European Medical Device…

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MEDDEV 2.7/1 - Revision of an essential guideline for the…

19 Oct 2016

Previously, we reported on the European requirements of clinical evaluation of your medical device, throughout the whole life-cycle of your…

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Through teamwork and individual perseverance, the finish line will be…

03 Oct 2016

After successful completion of the half marathon in Paris earlier this year, employees of Factory-CRO were full of enthusiasm to…

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Patient Centricity in class I, II or III medical device…

19 Sep 2016

Over the past few years, patient centricity has become a much heard buzz-word when discussing health care and health care…

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Reflection on Race & Ethnicity in medical device studies and…

01 Sep 2016

In June 2016, the FDA distributed a draft guidance document on evaluation and reporting of age, race, and ethnicity data…

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Clinical Evaluation – A continuous process

08 Jul 2016

Likely one of the most challenging requirements in the upcoming European Medical Device Regulation (MDR) and European IVD Regulation (IVDR)…

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Am I wearing a medical device?

22 Jun 2016

Working in Factory CRO’s clinical operations team, it’s all about collecting data and setting up clinical trials. As a movement…

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Kester Capital Announces investment in Factory-CRO

01 Jun 2016

Kester Capital is pleased to announce an investment in Factory-CRO, a leading CRO focused on the medical device market. Factory-CRO was…

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Post market surveillance - Not just a second-class clinical investigation

27 May 2016

The clinical demonstration of safety and performance of your device is an essential premarket conformity assessment specified under Annex I,…

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Niels van Tienen

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

Meet the team