Regulatory Consulting / Clinical Evaluation of Medical Devices

You are a medical device manufacturer ?

Our team specialized in medical devices supports you in the regulatory and clinical development of your device as well as in its clinical evaluation, in accordance with European Regulation 2017/745.

According to you needs, RCTs can counsel you on:

The class and status of your device
The necessary steps to obtain CE-marking
The clinical use of your device (intended use, indication, population and users)
The clinical claims of your device (performance, benefit and safety)
The regulatory and clinical strategy to implement


RCTs also supports you, from A to Z, in the conduct of the clinical evaluation of your device:

Definition of the clinical evaluation strategy (own clinical data, equivalence, Well-Established Technology or Article 61(10))
Writing of the Clinical Evaluation Plan (CEP)
Conduct of the evaluation and witing of the Clinical Evaluation Report (CER)
Definition of the post-market clinical follow-up strategy
Writing of the Post-Market Clinical Follow-up Plan (PMCFP)


RCTs’ clinical evaluation in key figures:

+70 Clinical evaluation conducted by experts
On medical devices of all 3 classes : I, IIa, IIb, III
Including implants, software and devices without medical intended prupose
4 Using all type of strategies: own clinical data, equivalence, WET and article 61 (10)



Free webinars dedicated to the clinical evaluation:

webinars dm

RCTs organized a series of free webinars (in French) dedicated to the clinical evaluation of medical devices. Find out more about these webinars here.

Our experts are available for you

Morgane Champiot
Head of Clinical Operations - Co-leader of the AFCROs’ Medical Device working group
Sara Guillemin
Medical Device Regulatory Manager & Medical Writer

Next expertise

Early / Compassionate Use Learn more

Do you need a strong
partner to rely on ?


Let’s talk about it