Kapstone Medical assists with medical device testing in all facets of product development. As a consultant to your internal team or as project managers taking on overall responsibility for a new projects, we identify the right tests to conduct, compose test protocols, coordinate the test, and write test reports. Certain tests we can complete in-house but many regulatory submission tests will be conducted at our multiple trusted third-party accredited test labs. We are experts at achieving the appropriate testing and ensuring that testing is done efficiently and effectively.
Initial Testing & Analysis
We are often tasked with early characterization of new products. This may involve computer modeling and Finite Element Analysis (FEA) or may include bench testing on physical prototypes. Either way, our team is poised to complete initial analysis and testing quickly and cost effectively as part of a “Phase 0” project.
Testing progresses according to a written plan that dovetails with the engineering design plan, regulatory assessment and quality documentation requirements for the project.
Design Validation
Validation asks a very different question than verification does. The point of design validation is to determine whether developers designed the correct device - that it meets the original user needs.
Typical design validation tests that Kapstone handles:
- User or usability testing
- Cadaver testing
- Packaging, including aging testing
- Shelf life and lifetime testing
- Sterilization testing
- Transportation testing
Process Validation
Kapstone can also handle process validations. Read more on our Manufacturing page.
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