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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Questions?

We look forward to answering your questions and
helping you with the development of your device.

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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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Latest news

Audits - a quality control tool that can’t be absent in a product development program

28 Nov 2016

Nowadays, it becomes more and more important to control the various stages and (outsourced) processes in the development of a…

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

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…

MEDDEV 2.7/1 - Revision of an essential guideline for the European medical device market

19 Oct 2016

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

Evelyn Groot

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

Meet the team