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.


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In June 2016, the FDA distributed a draft guidance document on evaluation and reporting of age, race, and ethnicity data…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

04 May 2016

On May 3rth, 2016, Factory CRO was audited based upon the ISO13485:2003 and ISO9001:2008 audit criteria by the DEKRA. We…

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Monitoring in investigator-initiated clinical trials

04 May 2016

A research to barriers that impede adherence to national monitoring guidelines In response to major incidences of fraud, data-manipulation and misconduct…

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The medical device industry - A catalyst for regulatory innovations

19 Apr 2016

The regulators versus the medical device industry, who’s in the lead? In the perpetual developing environment of medical devices, international…

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Evelyn Groot

I get satisfaction because I am contributing to something useful, I am helping people.

Meet the team