As the innovation of medical devices evolves, the industry standards and requirements for consistently high quality standards as demanded by society’s wants and needs are also constantly changing. Product testing has two aspects as declared by the FDA, validation and verification—with the conclusion that all parts and components of the products have been maintained. Validation and verification testing processes may both involve testing, analysis, and inspections. Controlled simulations create a baseline for testing environments during development and implementation. Specific hazards or feature changes are targeted in various trials, improving the capabilities of the product to perform to its necessary functions. Regression testing, conversely, can be used to ensure the product does not stray from the baseline standards while changes to the device are being made. At the end of the process, testing documents are recollected for outlining that appropriate processes were taken for reporting improvements and defects. When verification and validation processes are effectively combined, the development of the product will not only fulfil the user’s needs, but also most importantly FDA regulations.
Validation testing is the dynamic testing process that can be thought of as “building the system right”. Typically, validation testing is more subjective and involves user simulated experiences with both software and hardware. A common example of this is black-box white-box testing. On the black-box testing side, the user is not aware of the specifications of the product as might a new customer that is unfamiliar or “kept in the dark” about the product. This form of testing may review factors of the overall outlook of the product that are completely new based on the subject’s needs. On the white-box testing side, the user is aware of the specifications of the product and has the expertise to ensure that the product is meeting the high quality expectations that are sought after. This developer’s view is more concise in testing areas of the product that are particularly significant, as well as capable of providing insight in where improvements can be made. Everything from user interface to packaging to temperature control is reviewed for their effect on functionality and performance, then changes are made to maintain consistency in the final product. The medical device should be meeting the expectations of the users intended needs in actual conditions.
Verification testing is the static testing process that can be thought of as “building the right system”. Contrary to validation, verification is objective and goal oriented towards satisfying official safety and functionality standards. The form of testing in verification as a result tends to be less about simulated tests as in validation, but check-ins that the medical device meets the necessary requirements set at the beginning for quality assurance that become more comprehensive overtime. Often these refer to Product Requirements Specifications (PDRS) and Hardware Requirements Specifications (HWRS) that set standards for what must be taken into consideration by the end product.
Efficiency in Cohesion
Sterling undergoes comprehensive planning for product testing in order to create satisfactory products. To maximize efficiency while taking all forms of testing into consideration, products are tested cohesively to complete requirements on both sides of verification and validation mitigating as much room for error as possible. Verification testing is periodically maintained through each phase of design and development, in intervals from start to finish. Due to this, a production equivalent unit is not required for verification. However production equivalent units are required in validation. It is assumed that a product equivalent unit has met all requirements for verification by the end of verification testing, allowing for a “frozen design” to compare to during validation. Being able to understand the relationship between validation and verification streamlines a reliable, high quality product to market.