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Verification and Validation, often shortened to V&V, is a vital step in the development of any software, but is especially imperative for software in a medical device, software as a medical device or software as an accessory to a medical device. Featuring prominently in applicable standards and guidance from regulatory bodies, the importance of V&V cannot be understated in producing a safe, effective and reliable software of any kind. 

While often referenced together and undoubtedly interlinked, verification and validation serve different purposes: 

  • Verification is testing that the product meets the requirements and design specification, as is needed to implement the desired functionality without bugs or issues. Simply put, it answers the question "Have we built the product correctly?"
  • Validation is testing how well the end product addresses the user and business needs that were the root cause for developing the product Simply put, it answers the question "Have we built the correct product?"

In Connected Diagnostics' experience, manufacturers of medical devices often place a lot of emphasis on the verification, rightly so to ensure the safe, correct and proper working of the software. However, validation is often overlooked or underutilised as an essential stage of the quality assurance process,especially if the software has no direct medical application or patient safety implications, as may be the case for some medical device accessory software

This is misguided, as a comprehensive validation strategy, which includes end user acceptance testing, is of equal importance to guarantee that the product meets the needs and expectations of end users, which ultimately should be the driving force behind the necessity for the product.

The benefits of user led validation are numerous:

  • Early identification of software issues only present in a real-world environment
  • Confirmation that the software conforms to the needs of end users.  
  • Provides early feedback and insights intofunctionality and usability to improve the software release (which is especially useful when built into an agile process). 
  • Ultimately reduce the number of reworks and releases of the software, thus saving time and money. 
  • Improves the ability of sales departments to push a product which has been validated and approved by end users.

Consequently, a good quality assurance strategy should aim to ensure the overall quality and value of the product holisticallyFocusing not just on the verification, but also validation by internal stakeholders and real-world end users through activities such as user acceptance testing

As experts in eHealth, Connected Diagnostics can assist in the design and execution of a complete quality assurance strategy for medical software of any type or category, including an appropriate and extensive validation plan.


Ashley Meredith

Connected Diagnostics