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In a world of rapidly evolving technology, can we maintain regulatory clarity?

This was the question asked at a recent roundtable discussion hosted by BioMelbourne Network. Invited by the TGA, industry representatives were brought together to assess the new Software as a Medical Device (SaMD) guidance on the application of appropriate quality management systems.

This is the latest document issued by the International Medical Device Regulators Forum (IMDRF) in what will be a series of harmonised guidelines. The authors are attempting to bridge the gap between the general QMS principles offered by the ISO 9000 family, the many and varied software engineering quality standards and the QMS requirements that pertain specifically to medical devices, namely ISO 13485.

The draft document addresses each of the key aspects of a QMS as it applies to SaMD, with some useful case studies and examples to assist with understanding their application. IMDRF has stated that, “The IMDRF seeks to establish a common and converged understanding for software intended for medical purposes and specifically for a subset of such software that is intended to function as a medical device.”

Documents already issued (and available on the IMDRF website) address common vocabulary and understanding of SaMD for both manufacturers and regulators, as well as risk categorisation.

One of the key areas for improvement will likely be in relation to the use of third party platforms where maintenance, change management and post-implementation feedback will need to be managed. In addition, requirements for SOUP (software of uncertain provenance) is also an important area to get right, as this may impact software development. Other items such as risk management, control over source code libraries and open source code and record retention will also be key to the success of the issued guideline. Consultation on this guideline was requested by the TGA prior to end May 2015.

If this series of guidelines is likely to impact your business, keep an eye out for the final version and ensure you have input in the development of related documents.

Commercial Eyes’ team of Regulatory Services experts are ready and able to assist you with your medical device needs. Call us on +61 3 9251 0777 to confirm whether your product is a medical device and to discuss how these guidelines impact your business.

This article was written by Jeanette Lodge, one of our Regulatory Services Managers.

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