Medical Devices Engineering & Regulatory Support

Medical
Devices Engineering

Regulatory and CE Marking Support

ISO 13485
Quality
Management

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 

<strong>Fields of expertise :</strong> <ul> <li>Assuring the normative compatibility of a R&D plan for a medical device with an objective of CE marking.</li> <li>Understanding the problematic from the scientist's point of view and designing the solution as an appropriate medical device.</li> <li>Defining both production and market cycles of a MD by managing subcontracting according to ISO13485 requirements.</li> <li>Providing the technical design file of a MD, and training engineer teams in charge of R&D.</li> </ul>
Fields of expertise :
  • 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.
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Emmanuel BOUIX

MD Regulatory Affairs Specialist

Since 2013

PhD in Computer Science

<strong>Fields of expertise :</strong> <ul> <li>Implementing specifications and design of medical devices driven by the normative requirements of the sector.</li> <li>Implementing risk management, software validation and usability engineering processes.</li> <li>Defining both production and market processes in accordance with requirements of the ISO 13485 standard.</li> <li>Providing and reviewing of technical file of a medical device in accordance with MDD 93/42/EEC and MDR 2017/745.</li> <li>Training of project teams in charge of the development of medical devices.</li> </ul>
Fields of expertise :
  • 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.
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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.

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