Engineering Services

Contracting and consulting services covering from local to global mass-manufacturing environments, global supply chains and R&D.

+10 years

Medical Device
Life Cycle Activities

+9 years

Maintaining
Global Supply Chains

+8 years

Lean Six Sigma
Implementation

Entire Life Cycle

  • Heavily Regulated Industries
    • Medical Devices
    • Pharmaceutical
    • Automotive
  • Production, Products and Services
  • Complete Life Cycle Support

Our Services

  • Complete coverage of the entire device/service life cycle
  • Engineering Activities (see tabs for further details);
    • Pre-Market Activities
    • Post-Market Activities
    • Device Development, Service, and Troubleshooting
  • Regulatory Activities;
    • Device / Service Commercial Approvals
    • Deviation Management

Covered Regulatory Frameworks

  • EU MDR 2017/745
  • EU AI-MDD / EU MDD
  • FDA 21 CFR Part 820

Devices Classes and Types

  • [EU MDR 2017/745]:
    • Invasive and Permanent
    • Class I/s/r/m/mr, IIa, IIb, III
    • Passive and Active
    • Restorative and Life Supporting
    • Hardware and Software