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.
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)