Full Service 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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REGULATORY SERVICES

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.

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CLINICAL TRIAL SERVICES

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

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.

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In June 2016, the FDA distributed a draft guidance document on evaluation and reporting of age, race, and ethnicity data…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