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

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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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  • Pre-study & initiation visits
  • Monitoring visits
  • Source document verification
  • Close out visits
  • 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
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
554 Fourth Avenue, San Diego, US

AAOS 2017 Networking reception and happy hour

Factory CRO will co-host the AAOS 2017 Networking reception & happy hour that will be organized during the 2017 Annual Meeting of the American Academy of Orthopedic Surgeons (AAOS) (March 14-18th, 2017, San Diego, California). Please join Medical Metrics, Milestone Research,...

Meetings & Seminars
San Diego, USA

AAOS 2017 Annual Meeting

Factory will attend the 2017 Annual Meeting of the American Academy of Orthopedic Surgeons (AAOS) (March 14-18th, 2017, San Diego, California) Founded in 1933, the Academy is the preeminent provider of musculoskeletal education to orthopaedic surgeons and others in the...

Meetings & Seminars
Dorpstraat 195, Bilthoven, The Netherlands

RAPS Chapter Netherlands

Factory will attend the 16th meeting of the Regulatory Affairs Professionals Society (RAPS) Chapter Netherlands (March 24th, Bilthoven, The Netherlands). The objective of the RAPS Netherlands Chapter is to bring together Dutch-speaking regulatory affairs professionals to exchange knowledge and experience and...

Meetings & Seminars
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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