Validations :: Medical Device Solutions

By: Medical Device Solutions  05/12/2011
Keywords: product development, Medical Device, regulatory requirements

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.

Keywords: Medical Device, Medical Device Companies, Medical Device Solutions, Performance qualification, Process Performance, product development, regulatory requirements

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