Validation Requirements:

Validation is the process of establishing objective evidence that a process or product consistently meets the requirements defined for it.

In addition to the validation of finished medical devices, the FDA also requires validation of software used as part of a production or quality system, and processes that cannot be fully verified by subsequent inspection and testing. In terms of both FDA and ISO frameworks, validation is an essential element in demonstrating the safety and effectiveness of medical devices.

Meeting the requirements:

The consultants at Ken Block Consulting have deep experience and expertise in creating and reviewing validation documents for a wide range of medical device manufacturers. The documents we assist with include validation master plans, validation protocols, and other related documents. Using a risk-based approach, KBC’s consultants work closely with clients to provide the applicable validation-related services. Since understanding of the regulations is an essential part of compliance, KBC also offers validation-related training, which is tailored to each client’s needs. Depending on the situation or needs, the training could take the form of anything from classroom seminars to one-on-one workshops and/or guidance.