Verification & Validation2018-03-13T12:09:03+00:00

Verification & Validation

As part of and/or in addition to Design Control aspects GPB provide support to you to design, implement, complete and maintain Master Verification and Validation Plans & File(s), Protocols & Test data.

man using tablet device

This can include changes / modifications for:

  • Software

    • Stand Alone
    • Embedded / part of device
  • Materials / Devices:

    • Biocompatibility Assessment & Testing to ISO 10993 Series
    • Electrical Safety to IEC 60601 Series
    • Packaging to ISO 11607 Series
    • Stability / Lifetime & Shelf-Life determination to ISO 23640 including accelerated to ASTM F1980 and real time studies as appropriate
    • Handling / Transport
  • Process Validation embracing:

    • Process Definition & Control
    • Formulation
    • Molding
    • Coating / Bonding
    • Manufacture / Assembly
    • Packaging / Sealing
    • Sterilisation, including Ethylene Oxide to ISO 11135, Radiation to ISO 11137, Moist Heat to 17665 and other methods such as Liquid Chemical Sterilisation and Vaporized Hydrogen Peroxide (VHP)
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