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.
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 verification activities are often lumped together with validation activities and generally referred to as “V&V”. While all elements of verification and validation may be mapped out in a single master plan and associated traceability matrix, it is important to handle them separately in order to obtain a thorough and accurate assessment of the characteristics of a medical device. Design verification ensures that the device was designed correctly - that it meets design inputs and performance requirements.
Typical design verification tests that Kapstone handles:
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:
Kapstone can also handle process validations. Read more on our Manufacturing page.