sonopill

Quality Management Systems (QMS) have been developed as a means to ensure controlled, standardised production of goods and services, so you know each time you'll get the same as before. Many people will have seen the old BSI kitemark or CE mark on products denoting that at some level you can trust it. Perhaps you've heard of ISO 9001.

As the Sonopill programme matures, it is producing technologies, and devices which incorporate them. THe ultimate goal is for them to be used in humans. In order to get there we need to do trials in humans. These trials require us to ensure that we've done everything we can to make the device safe for use. Commercially, most medical device companies would use a variant of ISO 9001, ISO 13485. Instead of striving for constant improvement, ISO 13485 aims to ensure stability of product.

Universities, research, thrive on the unexpected, even failures are useful, and there needs to be a dynamic, changing process of thoughtful enquiry. In many ways this is the antithesis of a locked down design, tested, tested, tested to ensure no harm.

In the coming months we will be implementing steps to ensure we meet the Medical Device Directive enabling us to apply for human trials. As part of this we will begin to put in place quality systems and processes. But the magic is to strike the right balance, not impeding research progress but enabling new devices to aid man.

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First published: 18 October 2017