Research & Development
Full support for the design and development of safe, high-performance medical devices, in compliance with current regulations.
Innovate with confidence
AIRMEDICE knows that research and development are crucial steps in order to ensure the safety and performance of your medical devices.
We offer you customised support during the design and development of your healthcare products, incorporating regulatory and standard elements right from the start design.
Our aim is to help you meet the strictest regulatory and standards requirements and optimise the time-to-market for your products.
An expert by your side for the development of your healthcare products.
We support you in all your projects, from the design to the inspection by notified bodies, including risk management and continuous improvement throughout the development cycle.
From project management to test management, you’ll save a considerable amount of time at the design stages, allowing you to optimise your time-to-market.
A non-exhaustive list and any request can be assessed.
From design to marketing, we support you every step of the way.
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
