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Medical Electronics Product Design UK
"MLE possesses a remarkable technical ability; they are brilliant at understanding a brief and are very passionate and sincere about providing a good result. We would recommend them to anyone and wouldn't dream of going anywhere else."
Peter Gibson - CEO, Plasma Surgical
We have many years of experience designing for the highly specialised, regulatory controlled, safety-critical medical and healthcare market places, for medical device design and healthcare product development, including experience of designing electronic products that would require typically FDA 510k approval, ISO13485 and also IEC60601, the UK/European medical device directive. Within these standards there are many stringent validation and verification requirements, for example ultra-low leakage current requirements for surgical laparoscopic devices.
We are also familiar with the supporting documentation for the application of approvals for products in your market place and the processes required to ensure safety aspects of the electronics design are covered. One of the critical aspects of your medical product design is how we satisfy the safety requirements. Our experience of how we can reduce risk by the best use of hardware and software interlocks, and failure mode risk analysis (FMRA), can simplify a design and reduce costs enormously.
Why Plasma Surgical chose MLE to develop a groundbreaking new product
We deliver cutting edge solutions every single day - such as the groundbreaking new product we developed for Plasma Surgical.
Plasma Surgical came to us for help in harnessing complex plasma technology for medical use, and the result was the PlasmaJet® - an innovative device that coagulates bleeding tissues using a jet of argon plasma; which is so effective it can reduce patient risk during surgery and shorten hospital stay.
Plasma Surgical chose us for this exciting project, not only because we have two of the UK's leading power supply engineers on our team, or our extensive capabilities in embedded control, medical electronics design and manufacture, but also because of our enthusiasm, empathy and our ability to really understand what was required for this project. Plasma Surgical found a genuinely client-focused partner who could exceed all of their expectations when it comes to developing innovative solutions.
Now approved by the FDA, the Society of Laparoendoscopic Surgeons awarded the PlasmaJet® with the Innovation of the Year Award for 2008; it is also considered as one of the most significant new products at the American College of Surgeons. The PlasmaJet® is currently entering production to meet UK and worldwide demand - and we are looking forward to continually evolving and upgrading the product for many years to come.
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