Verification and Validation; Requirements in Medical Device Design


The process of verification and validation is a critical component for the effective development and design of medical devices. Besides the ultimate need to comply with regulations, keeping the design, manufacture and user requirements in mind during development helps facilitate efficient transition from phase to phase of your medical device project. Putting in place and adhering to the proper production processes yields instruments with a higher manufacturing rate, fewer mistakes, a quicker time to market, and lower production costs. At KMC Systems, quality is not just a requirement, it's our culture.


The process of verification is to ensure that a product meets a certain set of design specifications where simulation tests are performed and analyzed, and the product is evaluated for regulatory compliance. This verification process is discussed by Terri Faucher, Principal Quality Engineer at KMC Systems.

 1.  When do you consider verification and validation during the total product life cycle of  medical device development?

  • System Verification and Software Verification & Validation (V&V) efforts start in the Development Phase and continue through transition to the Production Phase.  Sample size and how requirements will be verified should be considered early stages of  development in order for proper planning and incorporation of features to support test. 
  • System Verification typically takes place on pilot units.  Formal verification is performed on pilot or production units where the unit configuration is controlled and units are built under manufacturing control. The configuration becomes part of the verification traceability.

2.  What are the steps that go into verification and validation?

  • A System Verification Plan is written, which include sample size rationale and justification.  Verification Test Procedures are written to verify all of the requirements in the System Requirements and applicable risk mitigations.  A Traceability Matrix is created to trace Verification Test Procedure(s) to the System Requirements and the risk mitigation requirements defined by the risk analysis. 
  • It is good practice to go through one or more dry runs on executing test procedures to identify problems in test protocols. It is better to correct or improve the procedures before they are approved and executed.
  • The Verification Test Procedures must be approved prior to the start of verification testing.  After verification is executed, a System Verification Report is written and approved that summarizes all pertinent information generated during the execution of the verification procedures.

Verification and validation are an integral part of KMC Systems' robust quality assurance proven processes, which allows for the successful design and development of medical device instrumentation.

To learn more about KMC Systems' quality assurance best practices, download the tip sheet here.
KMC Quality Assurance Tip Sheet


Topics: medical device design, quality assurance