Since 1999, we have supported our customers with the aim to meet their needs, integrating these needs into our offers and legislative and regulatory standards relating to their medical devices and their markets.
Isocèle Conseil also provides a European representative service.
Our team is at your service to support you in your project:
- Identification of the regulatory strategy for the commercial release of your devices on targeted markets
- Regulatory compliance (CE marking, international approval)
- Setting up of quality management systems (ISO 13485 version 2016, MDSAP)
- Performance of your internal audits as well as audits at your sub-contractors’ premises by our consultants qualified in EN ISO and MDSAP standards
- Definition of strategy and formalization of clinical trial applications
- Formalization of clinical evaluation files according to the MEDDEV guidelines in force
- Legal and regulatory monitoring based on an annual set fee
- Training in standards and requirements