Questions?

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

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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

We are well acquainted with CE-marking requirements and FDA regulations and can assure that your study can be designed and controlled to meet the demands of Notified Bodies and FDA, in both the pre-market and the post-market phase of your product.

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CLINICAL TRIAL SERVICES

  • Pre-study visits
  • Initiation visits
  • Monitoring visits
  • Close out visits
  • Source document verification
  • Trial document handling
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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, blogs and events

December 30, 2016

Notified bodies under pressure

After our recent posts on the proposed Medical Device Regulation (MDR) and MEDDEV 2.7/1 rev. 4, it is interesting to shift our perspective, aiming to get a sense of the potential impact of the new regulatory framework for the medical...

Advanced
Regulatory
Life Cycle
April 6, 2017

Medical apps under the new European MDR

Worldwide 1 out of every 3 internet users currently monitors their health or fitness using an app. This was shown in a recent survey by market researcher GfK. Millions of health-related apps are downloaded every year, and this is expected...

Starter
Regulatory
Pre Market
November 28, 2016

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

Nowadays, it becomes more and more important to control the various stages and (outsourced) processes in the development of a medical device. It is therefore not surprising that the revised ISO 13485:2016 is more stringent when it comes to (outsourcing) processes....

Expert
Regulatory
Post Market
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Evelyn Groot

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

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