Documentation

Our program management team controls all documentation in a project file or a design history file, depending on the quality system we use to control development. We conduct a phase-end design review to review all tasks against the development plan and ultimately release all documentation into the quality system.

Reporting

At the end of the Verification & Validation phase, our program management team leads a final design review to verify that we have met all design requirements, closed all risk management items, and completed all tasks in the development plan, risk plan, verification plan, and validation plan. We complete the device master record (DMR) and device history record (DHR).

Verification & Validation Prototypes

We build verification and validation prototypes using released procedures, manufacturing processes representative of the commercial production process, and full material traceability. We may build verification prototypes using final procedures and tooling, but this depends on the device's complexity and the prototype volumes necessary. In some cases, we may need to assemble these prototypes manually with fixtures representative of automated machinery, in which case, we validate those assembly processes. We may package and sterilize prototypes for animal or clinical testing to support design validation activities. Prototypes may also undergo age testing, packaging and shipping testing, biocompatibility testing, or agency testing for certification to appropriate standards. 

Testing

We provide testing to support the design and development of medical devices, including biocompatibility, feasibility, verification, and validation testing. We will utilize external testing laboratories when necessary.

Verification Testing

We test verification prototypes to ensure that they meet their specified design requirements and perform as intended according to predefined criteria. We perform verification testing on prototypes representing the final product, with fully documented processes and material traceability using final protocols. We provide accelerated ageing and environmental conditioning testing if necessary.

Validation Testing

We test validation prototypes to ensure that they meet all of the user's needs. We support validation testing with devices produced using production processes and help qualified clinical personnel conduct testing according to released protocols.