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Clinical and regulatory affairs

 

Regulatory Diagnosis
Ideal for start-up businesses


   Regulations can be an obstacle for innovative projects, especially for associates who have technical training or have never worked in medical devices field. A good knowledge of regulatory requirements helps you designing your product with serenity and a global vision of CE mark.

   After analyzing your device or concept, NEOMED Services helps you in identifying and applying European standards.

Clinical evaluation file
Making your clinical data scientific, regulatory and marketing assets


NEOMED Services supports you in :

Defining the clinical strategy ;
Defining safety and performance requirements of your medical device ;
Identifying relevant clinical data ;
Drafting clinical evaluation report ;
Organizing clinical studies.

Risk management
A useful and effective tool


NEOMED Services gives you support in :

Initiating or improving your risk management process ;
Drafting your risk management records (risk management plan, risk management report etc.) ;
Managers training.

Certification
Technical files for CE mark


NEOMED Services helps you in :

Technical report/product report drafting assistance ;
Editing the regulatory documentation ;
Medical device vigilance ;
Support in creating your marketing documents in compliance with EU regulation.

Accompanying documents
Efficiently inform your customers complying with regulations


NEOMED Services supports you in :

Drafting instructions for use and labeling of your product ;
Checking your accompanying documents in compliance with regulations.

Post market surveillance
An effective surveillance or your medical device to add value to your post market data


NEOMED Services guides you for :

Setting up your post-market surveillance strategy ;
Organizing your post-market clinical follow-up (PMCF) ;
The implementation of preventive and corrective actions ;
Updating technical files (clinical evaluation file, risk management report, CE technical files, accompanying documents) according to the data collected.

NEOMED Services
ZI Douai-Dorignies
Rue Becquerel
59500 DOUAI

Phone : +33 3 27 94 41 13