Medical Devices Engineering & Regulatory Support
Our Specialists
Specialists in medical device development, but not just…
Our specialists are primarily innovation, research and development, IT, electronics and mechanics engineers.
Matthias FLEGAR
Innovation, R&D and DM Engineering Specialist
Since 2011
Electronics & IT Engineer

- Assuring the normative compatibility of a R&D plan for a medical device with an objective of CE marking.
- Understanding the problematic from the scientist's point of view and designing the solution as an appropriate medical device.
- Defining both production and market cycles of a MD by managing subcontracting according to ISO13485 requirements.
- Providing the technical design file of a MD, and training engineer teams in charge of R&D.
Emmanuel BOUIX
MD Regulatory Affairs Specialist
Since 2013
PhD in Computer Science

- Implementing specifications and design of medical devices driven by the normative requirements of the sector.
- Implementing risk management, software validation and usability engineering processes.
- Defining both production and market processes in accordance with requirements of the ISO 13485 standard.
- Providing and reviewing of technical file of a medical device in accordance with MDD 93/42/EEC and MDR 2017/745.
- Training of project teams in charge of the development of medical devices.
Our Background
Expertise DM is a team of engineers from AGUILA Technologies, composed of people from strongly regulated environments (Medical, Aeronautics, Automotive, Safety), which has been working in DM sector since 2009.
In order to assist our customers in the process of CE marking of their medical devices, our team has been trained on the ISO 13485 quality management system of companies in this sector.
Due to the know-how capitalized in recent years, we have the capacity to support you in the success of your projects of development and certification of medical devices.
Collectice Intelligence
Innovation
Expertises
Our specialists assist you in your medical device projects
Depending on the maturity of your project, AGUILA provides services adapted to meet your needs.