October 17, 2013
A risk assessment is not just an essential component of any medical device development programme – it can also be a very effective design input.
The challenge is that many tools and techniques used are time consuming, and are based on a single snap-shot of the design.
Unfortunately, this does not fit with a medical device – especially large complex systems – that is progressing through a rapid development programme, and the risk assessment team often finds itself assessing an ‘earlier’ design which is no longer relevant.
At Cambridge Medtech Solutions, we use a ‘Real-time Risk Assessment’ approach that is quick, efficient and effective.
Crucially, it enables risk control interplay between electro-mechanical and software elements, addresses the requirements of the Medical Device Directive, and is consistent with ISO 14971:2012 and IEC 62304.
If you want to know more, and to explore how this approach can help you, then please contact us.