Since 1999, we have worked closely with our clients to meet their needs, incorporating those needs into our offerings along with the standards and regulatory requirements applicable to their medical devices and markets.
Our team is here to assist you with your project:
- Identifying the regulatory strategy for bringing your devices to market in your target markets
- Regulatory Compliance (CE Marking, International Approvals)
- Implementation of Quality Management Systems (ISO 13485, MDSAP, QMSR)
- Conducting your internal audits and audits at your subcontractors’ sites, performed by our “Lead Auditor” consultants
- Strategy development and submission of applications for clinical trials and performance evaluations
- Standardization of clinical evaluation and performance evaluation dossiers in accordance with current European Regulations and MDCG guidelines
- Legislative and Regulatory Monitoring Based on an Annual Flat Fee
- Provision of an outsourced Quality Manager and/or a Compliance Officer (PRRC)
- Training on Standards and Regulatory Requirements
Isocèle Conseil also provides services as a European representative.