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
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



Our specialists assist you in your medical device projects

Depending on the maturity of your project, AGUILA provides services adapted to meet your needs.