Validations

We offer Validation expertise to support both process and product development and launch activities.

Typical Process Validation activities that we provide to support the Validation Cycle are:

  • Failure Mode Effect Analysis (Process FMEA),
  • Validation Planning,
  • Variable and Attribute Sampling Plans,
  • Installation Qualification (IQ),
  • Software Validation,
  • Test Method Validation,
  • Operational Qualification (OQ) and
  • Process Performance Qualification (PPQ)

Typical Product Development Validation activities that we provide to support the Validation Cycle are:

  • Failure Mode Effect Analysis (Use and Design FMEA),
  • Validation Planning,
  • Variable and Attribute Sampling Plans,
  • Design Verification,
  • Design Validation,
  • Test Method Validation,
  • Product Performance Qualification (PPQ) and
  • Regulatory Requirements

We offer Validation expertise to start-up and existing Medical Device Companies engaged in the design and manufacture of medical devices.