Regulatory Affairs of Medical Devices
Full support to ensure the regulatory compliance of your medical devices, depending on the markets targeted.
Access markets without any stress
AIRMEDICE is aware that regulatory compliance is crucial for the medical industries and patient safety.
That’s why we offer you our recognised expertise and customised support to help you meet the strictest regulatory requirements, with deliverables that meet the expectations of the authorities so that you can market your healthcare products with absolute confidence.
Personalised support for your medical devices.
We support you during the life cycle of your medical devices, from defining your regulatory strategy to post-market surveillance.
We offer you customised follow-up tailored to your specific needs, taking into account the characteristics of your products and your commercial objectives.
A non-exhaustive list and any request can be assessed.
Ensure the compliance of your medical products and access global markets.
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
