Verification & Validation
Generation of plans, protocols and report in compliance with design control requirements (CFR 820.30) including:

  • Verification Master Plan
  • Traceability matrix
  • Test Method Validation (TMV)
  • Sterilization validation (EO, Heat, Radiation) according to ISO 17665, ISO 11137, AAMI TIR 16, ISO 11737, ISO 11135-1
  • Packaging & transportation Validation (ASTM D4169 , ISO 11607, ASTM D7386)
  • Environmental (ASTM D4332)
  • Shelf-life (ISO 11607)
  • Audio (IEC 60601-1-8)
  • Software (IEC 62304)
  • PSA (Pressure Sensitive Adhesives) – ASTM D3330, ASTM D3654, ASTM D6463, ASTM D6195

Hands on in-house execution (turnkey) of V&V program including:
  • Planning
  • Execution
  • Reporting