Knowledge insights

Effective Software Validation and Verification for Embedded Medical Devices


Following software validation and verification best practices, electronic medical devices manufacturers can meet their compliance goals and enhance developer productivity.

Today’s electronic medical devices manufacturers must satisfy a stringent regulatory environment. Both the European Community (through European Community directives) and the U.S. Food and Drug Administration (FDA) have developed regulations that must be satisfied before a medical device can be approved for use. Moreover these regulations are periodically introduced, reviewed and updated, putting manufacturers in a never ending effort to stay abreast of all necessary rules.

In addition to specifying requirements, these organizations also require electronic medical devices manufacturers to validate the software components embedded in their products. Software verification and validation practices that manufacturers integrate into their development processes should help them achieve compliance and productivity goals while developing software code.

Software verification and validation are two different concepts, even though many electronic medical device manufacturers frequently incorrectly interchange them. Verification tests whether a product delivers the required functionality to the customer. Validation tests whether the functionality of a product, as defined through verification, is the intended behavior of that product. Software validation is required by federal regulations.

Embedded software providers can play a crucial role in helping electronic medical device manufacturers meeting their compliance goals, providing them:

  • The insurance that all stages of the software development process are adequately documented and compliant with regulations, guidance documents and standards.
  • The assurance that the development process that has been planned is progressing according to the plan and that the software meets the needs of the stakeholders.

Proper software verification and validation activities must occur at every level of the software development life cycle and should demonstrate that all software requirements have been implemented properly and correctly.

It’s time for medical manufacturers to work smarter and reach software quality goals without losing their market shares. To read more on how the right partner for your next embedded software development project can help you meet your business objectives, visit Enea website.

By Enea Services

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