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


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

Learn more

  • 1
  • 2
  • 3


Our deep understanding of U.S. and European regulatory agencies ensures your study is designed to meet all pre- and post-market approval requirements. We can assist you with regulatory submissions and study progress reporting.

Read more


Our clinical team has extensive experience and knowledge in the clinical trial field, including monitoring & source document verification, trial document handling, and site visits (pre-study, initiation & close out).

Read more


Factory’s expert team of medical writers can support you in various ways, including clinical study design, protocol development, clinical evaluation, reporting of study results, and Investigator’s Brochure writing.

Read more

Latest news, blogs and events

February 8, 2018

Earn and Keep Your Market Share Through Reimbursement Support

Market adoption of new medical devices in the United States is largely dependent on the availability of an applicable CPT® code for use in reporting the services provided. Additionally, the existence of positive insurance medical policies outlining coverage for a...

Pre Market
February 27, 2018

One Medical Device Trial Fits All! ISO 14155 as a Standard for Your Foreign Data Submitted to the FDA

There is interesting news in the medical device world that may impact your clinical strategy! On February 21, 2018, the FDA released its final ruling on the acceptance of data from clinical investigations for medical devices. With this amendment to...

Pre Market
November 17, 2017

Start Sooner, Run Fast, Finish Faster – The New York Marathon 2017

At Factory CRO we believe that physical fitness stimulates people to get the best out of themselves. Besides the positive energy, it increases company engagement and team spirit. In light of this philosophy, 12 Factory CRO runners successfully completed the...

Pre Market
Embassy Suites by Hilton Las Vegas, 4315 Swenson Street, Las Vegas, NV, USA

510k Workshop – Medical Device Acedemy in Las Vegas

March 21-22, 2018 there is a two-day, Las Vegas 510k workshop for medical devices at the Embassy Suites Las Vegas. Factory-CRO's Director of Clinical Operations Niels van Tienen will be hosting a workshop about Clinical Study Testing (Section 20). Click...

Meetings & Seminars
Meadowlands Exposition Center, Plaza Drive, Secaucus, NJ, USA

MDTX (Medical Device Technology Exchange) 2018 Conference & Exhibition in Secaucus

MDTX is the place where the future of medical devices comes alive, putting you at the forefront of what's happening in the industry. Discover the latest in cutting-edge technologies and approaches of today, and prepare yourself for what's coming. You'll...

Meetings & Seminars
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