Medical Device Software Validation Challenges

Validating medical device software can be challenging, especially when the software is a component part of or is embedded within a more complex medical device. Not only is it neccesary to develop and test the software, but it must be validated in accordance with regulatory expectations, often with reference to the broader medical device.

In some cases software systems may be used to distribute or update medical devices software (e.g. for diagnostics systems or implantable devices) and additional controls are required to ensure that the right software can only be distributed to the right device, in markets for which the device is licensed.

In some cases large, mature medical device organizations may outsource the software development to a third party and in many cases small start up companies with little experience in software validation are leveraging software and/or information technology to differentiate innovative devices. In such cases it is essential that the software is appropriately validated from the start of the development process, thereby reducing costs and minimizing the time required to obtain regulatory approval and get new devices to market.

Support from Business & Decision

Whether a large multi-national medical devices corporation or a small University spin-off, validating medical device software needs to be right first time.

Business & Decision's consultants use their knowledge of risk-based software validation to ensure that not only is the medical device software validated, but that the validation process:

• Is appropriate to the classification (and risk) of the device, appropriately scaling the verification activities and documentation in accordance with the risk, complexity and technology of the software, 
• Is risk-based, linking the risk assessment of the software to the overall device risk assessment (usually conducted in accordance with ISO 14971), recognizing failure modes associated with the device and the risk probability and detectability that is specific to the software,
• Produces documentation that is suitable for inclusion within (or referenced from) the Device Master File,
• Supports the appropriate submission process(es), recognizing any specific submission requirements for the device category,
• Is part of an appropriate quality management system (21CFR Part 820 or ISO 13485 where applicable, or ISO 9000).

By considering all of these factors, Business & Decision's consultants ensure that not only is the software validated in a cost effective manner, but that the validation of the software supports other key business and regulatory processes required to bring a new product to market quickly and safely. Where appropriate Business & Decision can also provide guidance and advice on software development life cycle selection, help develop the necessary components of a supporting quality management system and can provide templates to help accelerate the process.

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