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

Learn more

Full Service CRO

Factory CRO offers the top services for consultancy, regulatory,
and clinical trial services as well as data management and

Learn more

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.

Learn more

  • 1
  • 2
  • 3


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.

Read more


  • Pre-study visits
  • Initiation visits
  • Monitoring visits
  • Close out visits
  • Source document verification
  • Trial document handling
Read more


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.

Read more

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...

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...

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....

Post Market
See all news & events

Annelies van Mourik

Factory has a very positive vibe. People are motivated and hard-working, but there is also a good work-life balance. Management stimulates social interaction and activities which is highly appreciated!

Meet the team