Ensuring quality, controlling compliance.
ISOMED Conseil offers expert support tailored to your Quality and Regulatory Affairs needs in the medical device industry.
About us
As an ISIFC biomedical engineer, I set up ISOMED Conseil in 2020 to help French start-ups in the medical sector to make rapid progress in a complex regulatory environment. My role is to give them the keys they need to evolve with agility in this environment by devising a winning strategy to obtain the necessary marketing authorisations for their products.
I came into this job after working for ten years in medical inductry as Quality Engineer.
This extensive professional experience now enables me to carry out consultancy assignments for companies, as well as fulfilling my role as a BPI France-approved expert advisor.
AFNOR Competences trainer, AFNOR Certification inspector, MD101 member ...
Already dozens of satisfied customers and confident partners. I look forward to working with you.
The keys to ISOMED Conseil support
Vigilance
What to report? To whom?
Advice
Strategic expertise to guide your projects in the best possible way.
Compliance
Ensuring compliance with current standards and regulations.
CE marking
Support in the European certification process.
Pragmatism
A practical, solution-oriented approach.
Audit
Rigorous assessment of your systems to ensure their effectiveness.
quality & technical offers
ISOMED Conseil can help you
on the following missions
ISOMED has developed cutting-edge expertise to support you in the following steps and ensure the success of your project in the complex regulatory environment of the medical sector.
Setting up a quality system based on ISO 13485
Design specifications
Risk management file
Software development process
SaMD validation
Post-market surveillance and Vigilance
Internal and supplier audits
Your expertise 50% financed by BPI France
As an expert consultant approved by BPI France, DIAG Dispositif Médical for sections 1 and 2 (implementation of the QMS and technical file), customers can benefit from 50% funding for the expert appraisal carried out by me.
regulatory offer
ISOMED Conseil explains regulations
Classification of medical devices
Classification of products according to their level of risk and intended use. This classification determines the regulatory requirements with which each device must comply in order to be placed on the market.
Regulatory analysis for market launch
Examining and interpreting regulatory requirements and standards that you shall address to put your device on the European or American market: explanation, roadmap, cost assessment.
Reassessment of technical documentation
Regular checking and updating the technical files of medical devices to ensure they comply with current standards. This includes reviewing pre-clinical data, manufacturing procedures, and information about safety and efficiency.
Cross-functional regulations (cybersecurity, AI, e-IFU)
Data protection, management of intelligent systems, and the provision of clear and accessible information through electronic notices. They aim to ensure the safety, efficiency and transparency of medical technologies, while protecting sensitive information.
Definition of PRRC
What is PRRC? Who is eligible for this role? What are his/her responsibilities? Don't be left without an answer. Call me.
ISOMED Conseil also offers training courses
All our training courses are distance learning for greater convenience. Quotes are available on request, and free of charge.
Introduction to ISO 13485 and medical device regulation
Basic knowledge of regulatory requirements
EN 62304 - Medical Device Software - Class A and B
Concepts and requirements of EN 62304, delivrables and processes.
SaMD : IEC 62304, IEC 82304-1 and ISO 14971
Software as a Medical Device: specific risk management and validation activities.
Contact us at
Infos contact
How to find us
9 lotissement les Tremblots 25510 Domprel, FRANCE
telephone
+33 7 49 60 06 29
carine@isomed.dev
SCHEDULES
Monday to Friday 08.00 - 18.00