Business & Decision Life Sciences has helped a number of medical device developers and manufactures to cost effectively validate software that is part of, or classified as, a medical device. This combines extensive knowledge of risk-based software validation best practices with knowledge of applicable medical device regulations.
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 necessary 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 startup 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.
Whether your company is a large multi-national medical devices corporation or a small university spin-off, validating medical device software needs to be right the first time.
Business & Decision Life Sciences’ 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:
By considering all of these factors, Business & Decision Life Sciences’ 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 Life Sciences can also provide guidance and advice on software development life cycle selection, help develop the necessary components of a supporting quality management system and provide templates to help accelerate the process.