Un problème, un conseil, des solutions
Nouveautés
Now referenced by BPI France, Medical Device DIAG!
Don't miss the New Regulation about Artificial Intelligence! Be ready for 2027!
Qualiopi certification for 2025!
ISOMED Conseil supports your activity and provides guidance on Quality and Regulatory matters in Medical Device industry.
Standalone Software, Electromedical device, active implantable device, ...
Services listed below are not exhaustiv. Every request is evaluated.
Technical and Quality Services
From design to market, assess your needs:
- Regulatory Analysis;
- Design Requirements;
- Embedded Software and MD that are themselves Software validation, according to IEC 62304;
- Suppliers and Internal Audits;
- Quality Management according to ISO 13485 ;
- Risk Management File creation or update according to ISO 14971;
- Post-market Surveillance.
Regulatory Services
In a very busy regulatory context, assess your gaps with the new Medical Device Regulation:
- Identify the class of your medical device according to the new MDR 2017/745;
- Re-assess your technical documentation;
- Define your Person Responsible for Regulatory Compliance;
- Regulatory analysis.
- Other duties: cybersecurity, e-IFU, Artificial Intelligence, ...
