Medical Device

Our Medical Device services are based on highly qualified consultants with +15 years of experience from many innovative Medical Device projects. Our services within Medical Device bridge all phases from product development through manufacturing development (e.g. pilot equipment) to validated production.

Our selection of services include:

      • Product development
      • 3D part design
      • Tolerance chain calculation
      • Creative sessions and innovation
      • Design for manufacturing and design control
      • Product risk management
      • HFE – Human factor engineering
      • UE – Usability engineering
      • Design verification and reviews
      • Specification and test of equipment (pilot and full scale),
      • Validation and Documentation (plans, protocols, test plans and reports)

When hiring Aptio, we apply our in-depth knowlegde and deep understanding of current and coming regulatory requirements such as:

      • MDD/MDR
      • FDA 21 CFR part 820
      • ISO 13485,
      • Usability Engineering EN 62366
      • UDI (unique device identification) and normal CE marking.

Design control is the backbone of our services, and we fully understand the importance of a structured and compliant development model. We handle

      • Medical Devices as well as Combination Products
      • We work both in CAPEX projects with development of new devices and with OPEX projects optimizing existing devices and related production.

Read more about our other services