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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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

February 22, 2019

As of TODAY you can collect clinical device data for your IDE or PMA outside of the USA

A year ago, the FDA published their final rule on the acceptability of medical-device clinical data collected outside of the USA (OUS) to support an IDE or device marketing application (1). Published in February 2018, the effective date of the...

Pre Market
March 1, 2019

No-deal Brexit Scenario: What Will Happen With The Medical Device Industry?

With 30 March 2019 approaching, the possibility of a no-deal Brexit is still very likely. What happens if a no-deal Brexit occurs? At Factory-CRO we have been thinking a lot about that scenario. Below are six key areas to consider...

Pre Market
February 13, 2019

VIDEO: Factory CRO Group

Medical device company looking to partner with a global CRO but do not want a generic approach to your clinical trial? At Factory-CRO Group we are focused, efficient and flexible and pride ourselves in creating a custom plan for each...

Pre Market
Westkanaaldijk 7, 3542 DA Utrecht, Netherlands

Technical Innovations in Medicine (TiiM) Congres

Vrijwel nergens gaan de technologische ontwikkelingen zo snel als in de gezondheidszorg. Baanbrekende mogelijkheden schieten de grond uit, waardoor de zorg van morgen er compleet anders uit zal zien. Deze ontwikkelingen gaan gepaard met grote uitdagingen. Hoe grijp je de...

Meetings & Seminars
Rue du Fossé aux Loups 47, Brussels, Belgium

RAPS Regulatory Affairs Conference Europe 2019

RAPS Regulatory Conference – Europe 2019 is the inaugural conference designed by European regulatory affairs professionals for European regulatory professionals. It’s where the regulatory community will gather to discuss the most pressing regulatory topics, share experiences and network with other...

Meetings & Seminars
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