Global Coverage

With offices in the U.S., Europe and the Caribbean, Factory CRO is one of the world’s leading CROs specializing only in medical devices and IVDs.

Learn more

Full-Service CRO

Factory CRO offers comprehensive consultancy, regulatory and clinical trial solutions as well as data management, statistics and reimbursement services.

Learn more

Questions?

We look forward to answering your questions and helping you with the development of your medical device or IVD, and/or your reimbursement challenges.

Learn more

  • 1
  • 2
  • 3

Regulatory Services

Our deep understanding of U.S. and European regulatory agencies ensures your study is designed to meet all pre- and post-market approval requirements.

Read more

Clinical Trial Services

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

Clinical Evaluation Services

Factory’s expert team of medical writers can conduct the clinical evaluation for you or support you in the clinical evaluation process.

Read more

Reimbursement Services

Our reimbursement strategy support services are available from conception through product launch and beyond.

Read more

Growing In North America

With Factory’s acquisition of MileStone Research Organization in San Diego — combined with our offices in Princeton, N.J.; Austin, Texas; Minneapolis and the San Francisco Bay area — we now offer a full range of clinical operations, regulatory, reimbursement and strategic development services in the U.S.

Read More

Latest news, blogs and events

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
October 26, 2017

Factory CRO Acquires MileStone Research Organization, Builds North American Presence

Bilthoven, Netherlands — Factory CRO, a leading global contract research organization focused on medical devices and IVDs, has announced the acquisition of MileStone Research Organization. MileStone, located in San Diego, specializes in clinical research and reimbursement solutions for the medical device...

Starter
Factory
Pre Market
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
See all news & events