Les prestations isocèle medical
Definition of the regulatory strategy
Define the regulatory strategy for your products, a key point from the very start of your project.
En savoir plusRegulatory compliance
On the basis of your project and regulatory compliance, identify and plan the steps.
En savoir plusObjective: risk-based approach for a simple and effective quality system
Objective: risk-based approach for a simple and effective quality system
En savoir plusInternal audits and sub-contractor audits
We perform your internal audits and sub-contractor audits.
En savoir plusClinical trial applications
Anticipate the need for clinical trials and submit the application to the health authorities.
En savoir plusClinical data evaluation report
Evaluation of clinical data prior to prior CE and Postmarket marking.
En savoir plusLegal and regulatory monitoring
Benefit from effective legal and regulatory monitoring
En savoir plusDirectives et règlements européens

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.
Les actualités
Isocèle Conseil is looking for experienced consultants
27 Sep.Isocèle Conseil is looking for experienced consultants to enhance the team.
Lire la suiteUpdating of the evaluation of clinical data according to the requirements of Regulation 2017/745
18 Jun. Lire la suiteDeadline for class 1 medical devices that change class with Regulation 2017/745
30 Nov. Lire la suite


