Quality Management
ADEQUAT EXPERTISE assists manufacturers in the creation, implementation and maintenance of their quality system, in a process of improvement and in compliance with applicable regulatory requirements.
The proposed solutions are personalized and adapted to the size of the company.
ADEQUAT EXPERTISE also offers outsourcing services for all or part of quality services: for example, audits (internal and suppliers), the management of the Quality department and its planning, the analysis of the efficiency of the quality system and its quality. process, training and awareness of employees and subcontractors.
Areas of expertise
- ISO 13485
- cGMP (FDA – 21CFR Part 820)
- French law of public health
- Animal tissue (ISO 22442 series)
- Biocompatibility (ISO 10993 series)
- Labeling and packaging (ISO 11607 series)
- Sterilisation radiation, ETO (ISO 11135 & ISO 11137 series)
- Clinical evaluation and clinical studies (ISO 14155)
- Risk management (ISO 14971, ISO 62366)
- Clean room (14644 series)
- Software validation (ISO 62304 – FDA 21CFR Part 11)
Services
- Creation and management of quality system
- Assistance for Certification
- Diagnostic
- Audit
- Preparation to inspection ANSM / FDA
- Subcontractors qualification
- Outsourcing service for Quality activities
- Supervision of the quality department
- Training
