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.

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Full Service Medical Device CRO

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

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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.

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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. We can assist you with regulatory submissions and study progress reporting.

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Clinical Trial Services

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).

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Medical Writing Services

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.

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Reimbursement Services

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

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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.

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Latest news, blogs and events

June 13, 2018

Five Corners joins Factory CRO

Bilthoven, Netherlands — Factory CRO, a leading global contract research organization (CRO) focused on medical devices and in vitro diagnostics (IVDs), has announced that Five Corners is joining Factory CRO. Five Corners is the premier device CRO in Australia, supporting the...

Starter
Factory
Pre Market
September 6, 2018

Risk Based Monitoring – A state of the art approach for your clinical investigation

Factory CRO witnesses and is part of a new trend in the clinical investigation landscape: Risk Based Monitoring (RBM). In this novel approach, focus lies on specific risks related to your clinical investigation, thereby more efficiently using resources, which improves...

Starter
Regulatory
Pre Market
May 24, 2018

Post-market surveillance under a “522 order”: Why, how and what?

Company X has gained 510k clearance for their new heart valve, and was notified by the Food and Drug Administration (FDA) that post-market surveillance (PMS) is required. Why did they receive it, what is it and what does it mean,...

Starter
Regulatory
Pre Market
26
Sep
Studio Tbd, 1070 Myra Ave, Los Angeles, CA 90029, USA

NASS (North American Spine society) 2018 conference in Los Angeles

NASS 2018 will feature the latest advancements in clinical management, the best researches carried out on respiratory diseases, symposia and workshops for the attendees. Sessions on clinical cases chaired by specialists will be there to understand various subject areas of...

Meetings & Seminars
26
Sep
ReeHorst, Ede, Netherlands

Dutch Clinical Research Foundation Annual Congress 2018

The Dutch clinical research Foundation's annual congress 2018 will be all about the implementation of the Medical Device Regulation (MDR) and its influence on Medical Device research in the Netherlands. Some experienced speakers will take you on a journey and...

Meetings & Seminars
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