Medial Devices
You are medical device manufacturer, subcontractor or distributor looking to turn regulatory compliance into an opportunity to improve your overall performance?
Quality system management ISO 135485
We specialize in the management of quality systems for medical devices and can help you update your quality system in accordance with the following standards ISO 13485:2016.
We support you in setting up and maintaining your system, in collaboration with your Quality Department and all the staff concerned, to obtain or maintain your certifications, taking into account new standards and regulatory requirements.
Process approach & Risk approach
Take advantage of the transition to regulation 2017/745 to implement or re-implement your ISO 13485 management system:
- Development and review of process mapping
- Definition of interactions between processes with internal pilots
- Creation of process flow diagrams
- Process documentation (procedures, operating modes, forms, etc.)
- Process risk analysis
- Definition and writing of quality policy
- Planning and monitoring objectives, translated into action plans
- Steering the Quality management system
- Implementation of relevant performance indicators
- Development of decision-support dashboards
- Management of medical device dossiers in collaboration with your in-house teams and our network of dedicated experts (risk analysis, clinical evaluations, biological evaluations, IAU fitness-for-use engineering, etc.)