Medical devices

Innovation for medicine

agap2 will advise you on the development and production of medical devices.

Our expertise

All our areas of expertise.

Engineering and R&D

  • HW and SW development
  • Automation
  • Mechanical & Electronics
  • V&V
  • Human Factor Use Ability


  • Quality Assurance
  • Quality Control
  • Deviations, anomalies, nonconformities
  • Setting up and CAPA follow-up
  • Chance control management

Regulatory Affairs

  • MDR Compliance, Writing and updating technical file (510K/CE Marking)
  • Specific regulatory requests
    Registration and renewal of MD
  • Regulation 2017/745 & Directive 93/42/CEE
  • Version management for the ISO 13485 Standard

Industrialization, Qualification and Validation

  • Revamping
  • Manufacturing support
  • Equipment qualification and Process validation
  • Validation of computerized systems (GAMP5, 21CFR part11)

Project Management

  • Risk management and budget planning
  • Lean management
  • Methods maintenance
  • Supply chain management
  • Purchasing
Our offer

A dedicated solution for every single project.

We recommend the collaboration model best suited to your specific needs. Drawing on 10 years of experience in engineering services, we’ve developed two collaboration models.

Technical assistance: we provide resources to support your assignments, ensuring tremendous agility and rapid responsiveness, especially for projects whose scope can frequently change.

Commitment to performance: we work on site for projects lasting over three months whereby specific goals are defined.


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