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

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

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
San Diego Convention Center, Harbor Drive, San Diego, Californië, Verenigde Staten

77th American Diabetes Association Scientific Sessions

Factory will attend the 77th American Diabetes Association Scientific Sessions on the 9th to 13th of June, 2017. Do you want to meet us there? Please don't hesitate to contact us in advance The Scientific Sessions Planning Committee has worked around...

Meetings & Seminars
Messe Wien Exhibition & Congress Center, Wenen, Oostenrijk

18th EFORT Congress, Sports activities and orthopaedic practice

Factory will attend the 18th EFORT (European Federation of National Associations of Orthopaedics and Traumatology) congress, main theme Sports activities and orthopaedic practice, on the 31st of May, 2017 to the 2nd of June, 2017. Do you want to meet...

Meetings & Seminars
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Niels van Tienen

At Factory we have short communication lines, making communication fast, effective and efficient.

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