Regulatory compliance

Isocèle Médical accompanies you in all medical device and in vitro medical device development steps.

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New European regulations and medical devices

What impact on your devices? What timescales? Regulations and quality system? Isocèle Médical helps you to understand

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ISO 13485 version 2016 quality management system

Isocèle Médical’s expertise for a simple and effective quality system.

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Legal and regulatory monitoring

Isocèle Médical manages the legal and regulatory monitoring of your medical devices and in vitro diagnostic medical devices for you.

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Isocèle Médical

+33 (0)2 47 52 63 80

All services by Isocèle Médical

Definition of the regulatory strategy

Define the regulatory strategy for your products, a key point from the very start of your project.

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Regulatory compliance

On the basis of your project and regulatory compliance, identify and plan the steps.

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Objective: risk-based approach for a simple and effective quality system

Objective: risk-based approach for a simple and effective quality system

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Internal audits and sub-contractor audits

We perform your internal audits and sub-contractor audits.

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Clinical trial applications

Anticipate the need for clinical trials and submit the application to the health authorities.

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Clinical data evaluation report

Evaluation of clinical data prior to prior CE and Postmarket marking.

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Legal and regulatory monitoring

Benefit from effective legal and regulatory monitoring

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European representative service

A high standard of service.

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Training

Isocèle Médical is a training organisation.

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For the past 20 years, Isocèle Conseil, Quality and Regulatory Affairs Consultants, has accompanied enterprises working in the medical sector (see references).

Isocèle Conseil believes in the pragmatic and controlled use of quality management at the service of the company’s performance.

Isocèle Conseil is recognised as an expert in the implementation of standards relating to medical devices, electromedical devices, and in vitro diagnostic medical devices.

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I met Catherine BACOU in May 2003, during a consultation designed to select our Quality Advisor in order to migrate our management system to ISO 13485. Her meticulous, precise, thorough, “hair splitting” character immediately convinced me that she was THE right choice for THERMOFINA!

Since then, we have continued to work together, standard after standard, decree after decree, with our improvements requirements and regulatory constraints being inexhaustible. And we are still completely satisfied with this partnership which, over the years, has become much more than just work.

Caroline GUILLAUME Thermofina

We have worked with Isocèle Conseil since 2011 and, in particular with Catherine BACOU who helped us build our ISO 13485 quality system and register our products as IVD medical devices in Europe and Canada. Catherine has always been effective and discerning in her approach and her advice is extremely useful. Her health expertise is huge and I strongly recommend her.

Jean François POMEROL Tribvn Healthcare

At the time (2013), embarking on the certification of a medical device appeared insurmountable for a small company such as mine (12 people). Very quickly, I understood that Catherine Bacou knew exactly what she was doing. Advice, availability, intelligence and above all, great experience in the field Eight years later, and despite changes in standards, I am never worried when it comes to audits because the system we have set up is effective, pragmatic and used by all our staff.

Julien VERON Eden Innovations

Catherine Bacou supported us as a consultant for two years, helping us to set up the procedures required for an ISO 13485 quality system, prepare the CE technical dossier, and the Santé Canada licence for our first product. We successfully passed the first ISO certification and CE marking audits just two years after the launch of Axilum Robotics despite starting from nothing! We are still in regular contact with her because we appreciate her great availability, her reactivity, and her distance with regard to all the key problems of medical devices.

Romuald Ginhoux Axilum Robotics

We have been assisted by Isocèle Conseil since 2017, the year DIANOSIC was created. We were immediately able to appreciate the team’s professionalism, pragmatism and flexibility, essential values for the success of a start-up such as our own. Emilie Fournier worked on the setting up of our quality system and helped to submit the CE marking application for our first product.

A strategic and operational pillar of our project, we see Emilie as an integral part of the DIANOSIC team. Apart from her technical skills and her business sense, her excellent interpersonal skills and contagious sense of humour are all indisputable assets. Entirely satisfied with this collaboration, I strongly recommend Isocèle Conseil to anyone looking for highly-qualified support as close as possible to the customer’s needs.

Philippe Bastide Dianosic

A young start-up in the medical devices sector, from the very start we wanted to learn good practices and invest in the quality of our future products. After creating the company, we requested the services of Isocèle Conseil in 2015, which helped us set up our ISO 13485 Quality System and draw up the CE marking files for our medical devices.

At the end of 2016, we increased their support with Raphaël Moustié intervening as “Outsourced Quality manager”, helping us to obtain ISO 13485 certification in 2017, then CE marking for our first product in 2018.

Isocèle’s expertise, the reactivity and follow-up work of its consultants, and the modularity of the support solutions are all extremely important elements for a start-up.
One great thing about their approach is that they always try to strike the right balance so that their recommendations are at the service of the organisation and not an obstacle to innovation.
We strongly recommend them.

David SIRET DAMAE Medical

Our news

Isocèle Conseil is looking for experienced consultants

27 Sep.

Isocèle Conseil is looking for experienced consultants to enhance the team.

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Updating of the evaluation of clinical data according to the requirements of Regulation 2017/745

18 Jun. Read more

Coronavirus Information – COVID-19

20 Mar. Read more

Deadline for class 1 medical devices that change class with Regulation 2017/745

30 Nov. Read more
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