Medical Device Engineering
An Engineering Team Dedicated to Medical Devices
By understanding the specific regulatory processes, specialised medical device engineering takes into account the requirements of medical standards and laboratory tests, in order to identify the technical issues and to select solutions that comply with these constraints right from the specification stage.
Our engineering service is specialized in the development of:
- medical devices
- connected medical devices
- software as a medical device (SaMD)
A Suitable Development Process
Our know-how enables us to cover all steps of the medical device life cycle.
Providing a technical file for a medical device is an essential step before put it on the market. We help our customers to develop it throughout the complete medical devices life cycle.
Answers to general safety and performance requirements
Needs identification
Definition of the applicable standards
Scope statement
Design and development – Specifications
Electronic, mechanical and software design
Useful life and / or expiry
Prototyping
Software Validation
Design file
Labelling and instructions for use
Pre-clinical evaluation
Electromagnetic compatibility tests
Electrical safety tests
Biocompatibility tests
Specific tests according to manufacturer's requirements
Definition of manufacturing processes
Identification of production subcontractors
Audits of critical subcontractors
Manufacturing and control processes
Test bench design and development
Conformity evaluation
Technical file
Identification of a notified body
Review of technical documentation and site audit
Marketing
Industrialization
Traceability
Materiovigilance
Our specialists assist you in your medical device projects
Depending on the maturity of your project, AGUILA provides services adapted to meet your needs.