Medical Device & Software Validation

person holding a smartphoneWhen the time comes to validate the your medical device software, no matter how far along you are in the development process, it is necessary to rely on an experienced partner that can independently guide you throughout the medical device software validation process. Our skilled team of experts here at Sterling Medical Devices can help you demonstrate that all of the software used for your medical device have the requirements implemented correctly and completely. Our team will also make sure that these software requirements are traceable to medical device system requirements to help ensure that you receive a successful FDA/CE mark submission. 

Medical device software is ever-evolving and medical device software developers are continuing to find ways to stay competitive and relevant within the medical device industry. When you consider how much more competitive the medical device market will become in the future, it is clear how software validation is critical to the success of you medical device projects. As your partner, Sterling Medical Devices brings value to the medical device development process. We give proper emphasis to medical device software validation throughout the many stages of the development lifecycle as a way to help our clients build medical device products the right way, the first time.

What is Software “Validation?”

Validation testing answers the simple question of “Are we building the right product?” This type of testing confirms that all of the users’ needs and intended uses for the device are met. Validation tests include, but are not limited to, usability, acceptance test, and, when necessary, comparing data with gold standards. Specifically, software validation almost always occurs in clinical, or patient-care, settings in which the finished medical device is used to ensure that it functions as it is intended to (i.e. control heart rhythm, measure heart rate, improve hearing, etc.).

The Importance of Software Validation

Software can be an essential part of your medical device, whether you are designing a brand new product or improving the functionality of an existing one. As medical device software continues to grow and expand across many new devices, patient safety must remain a top priority of medical device companies. The FDA is constantly monitoring and reporting on medical device issues, and failure to implement software controls or develop legitimate medical device software testing procedures can lead to issues within the software that ultimately cause a need for correction or removal of the device. A lack of software validation within the medical device developmental process can single-handedly alter patient safety, company reputation, and legal issues.

Software Validation Limits the Amount of Software Failure

Understanding the role that medical device software verification and validation (“V&V”) has in design, development and use is the first step to avoiding software failure and FDA recall. Although V&V testing is considered a critical part of the medical device development process, a lot of the time the value that it brings to medical device development is overlooked because it is not given the proper emphasis. All software (including software that has gone through V&V testing) is subject to failure after updates. This makes software validation critical at each point in a device’s life when its software undergoes a change. These changes within the medical device’s software are happening continuously to accommodate for technological advancements and evolving user needs, while also correcting existing errors within the software.

Other medical device verification and validation services:

  • Requirements review
  • Code and architectural review
  • Verification plan generation
  • Verification protocol generation
  • Safety testing
  • Unit module testing
  • White Box testing
  • Black Box testing
  • Protocol execution and reports
  • Automated testing
  • GMP process validation (IQ/OQ/PQ)
  • Usability and Human Factors Review

To learn more about Sterling’s other testing capabilities visit our Testing page.

To learn about how Sterling can help validate your device, complete a free analysis offer and we will have a Sterling representative contact you!


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