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

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
September 6, 2017

Unique Device Identification (UDI) System – Path toward Global Harmonization?

On Sept. 24, 2013, the Food & Drug Administration (FDA) mandated 78 FR 58786 (the UDI Rule), herewith establishing a unique device identification labeling system in line with the requirements of 21CFR830.20. Medical device labelers must submit product information to...

Starter
Regulatory
Life Cycle
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
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Welmoed Gjaltema

I like the dynamics, everyday is different. One day you’ll be at the office, another day you’re on site meeting new, different people.

Meet the team