Quality Assurance System and Product
Full support in implementing a quality management system (QMS) according to the ISO 13485 or 21 CFR Part 820.
Deploy a QMS that suits you
AIRMEDICE understands the importance of an effective quality management system, adapted to your structure and product typology.
We offer you customised support to implement a Quality Management System (QMS) specific to your organisation and obtain ISO 13485 or 21 CFR Part 820 certification.
Our expertise helps you meet the requirements of the most rigorous quality standards in the healthcare industry and maintain the efficiency of your system.
Continuous improvement at the core of your processes!
From defining processes to managing non-conformities, we provide you tailored, effective solutions to meet regulatory requirements and continuously improve the quality of your medical devices.
A non-exhaustive list and any request can be assessed.
Get ISO 13485 certification and ensure the compliance of your healthcare products.
EU medical devices regulation
2017/745/CE
Quality Management System
ISO 13485
Electromagnetic compatibility
IEC 60601-1-2
Electro-medical devices
IEC 60601-1
Usability
IEC 62366-1
Medical device software
IEC 62304
risk management
ISO 14971
Management systems audit
ISO 19001
