Qu’est ce qu’un essai clinique ?
15/02/2025
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Medical Devices
Rare Diseases
Pediatrics
Oncology
Neurology…
Your expert partner in clinical research
for medical devices
In an environment where regulations are constantly evolving, successfully developing and bringing a medical device to market requires both methodology and expertise.
We support medical device manufacturers at every stage of their project, ensuring strict compliance with European regulatory requirements:
- Definition of the regulatory strategy
- Demonstration of your product’s safety and performance
- Compliance with EU Regulation (EU) 2017/745
Our tailor-made support will help you turn these regulatory challenges into success stories.
Our Dedicated Services
for Medical Devices
Regulatory Strategy and Market Access
We support you in developing an optimal and efficient regulatory roadmap, fully aligned with European Regulation (EU) 2017/745 (MDR).
Our team stands by your side at every stage of interaction with Notified Bodies, Competent Authorities, and Health Authorities.
Clinical Evaluation
Through a rigorous and pragmatic working methodology, we document the clinical safety and performance of your medical device within its intended use, consolidating all evidence in the Clinical Evaluation Report (CER).
Clinical Investigations
Whether it involves a pre-CE marking investigation, a study conducted outside the product’s intended use, or a post-market clinical follow-up, our teams ensure the design, implementation, and management of your clinical investigations in full compliance with:
- Good Clinical Practice (GCP)
- ISO 14155 standard
- MDR requirements
Health Economics Assessments
Efficiency and the appropriate use of healthcare resources have become key priorities in this new quarter of the 21st century.
Through real-world studies or by collecting relevant variables during clinical investigations, a health economics analysis helps demonstrate the value delivered by your medical device.
This analysis highlights its organizational, social, ethical, economic, and clinical utility impacts.
The Key Steps to a Successful Clinical Evaluation
01Search for Existing Clinical Data
Collection of Studies and Available Information on Similar or Equivalent Devices
02Clinical Evaluation Strategy
Definition of Objectives and the Clinical Evaluation Plan (CEP)
03Extraction and Critical Review of Existing Clinical Data
Analysis of Data from Scientific Literature, Clinical Investigations, and Post-Market Surveillance of Similar or Equivalent Medical Devices
04Documentation of the State of the Art (SOTA)
Definition of Acceptance Criteria and Performance Specifications for Your Product
05Collection of Existing Data
Compilation of Data from Scientific Literature, Clinical Investigations, Vigilance Databases, and Customer or User Surveys Related to Your Medical Device
06Preparation of the Clinical Evaluation Report (CER)
Synthesis and Presentation of Results to Demonstrate the Safety and Performance of the Device
07Regulatory Validation
Interaction with Notified Bodies
Questions about regulations or your project?
Tout savoir sur les évaluations et investigations cliniquesCLINICAL INVESTIGATION:
a STRUCTURED and WELL-ESTABLISHED ORGANIZATION
01Study Design:
Definition of the investigation’s methodology and objectives, precise selection of appropriate endpoints, and identification and qualification of investigation sites.
02Regulatory and Ethical Approvals:
Obtaining approvals from Competent Authorities and Ethics Committee(s).
03Implementation of the Investigation:
Training of investigator teams, implementation of data collection and monitoring tools, and initiation of patient recruitment.
04Data Collection and Analysis:
Rigorous monitoring of patient enrollment and follow-up, data cleaning, and database lock.
05Final Report and Publication:
Statistical analysis of results and report writing.
Why Choose Euraxi for Your Medical Devices?
10+ years
of experience working
with Medical Device Manufacturers
with Medical Device Manufacturers
100+
projects completed
over the past 5 years
over the past 5 years
Secure the Certification and Market Access
of Your Medical Device
of Your Medical Device
Regulatory Compliance
at Every Step
at Every Step
Tailor-Made Strategy, Adapted to Your
Medical Device and Its Lifecycle
Medical Device and Its Lifecycle
Book a Meeting with a Euraxi Expert!
15 minutes to discuss your project and answer your questions.
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