Qualified for ISO13485 design and manufacture, MLE holds a wealth of experience in designing and developing a broad range of medical devices. These include point-of-care testing, drug delivery and tele-healthcare products, as well as surgical equipment, assisted living systems, technology demonstrators and clinical trial prototypes. In addition to maintaining up to the minute knowledge of early stage technologies, such as energy harvesting, the company can also offer regulatory support for CE marking.
ABOUT MLE Creative Electronics:/p>
www.ml-electronics.co.uk
MLE Creative Electronics is a highly approachable UK-based technology and product development company specialising in electronic product design, development and bespoke assembly services. Working in partnership with its customers MLE has helped to bring many novel products to market across a wide range of market sectors for companies such as Ferrari and QinetiQ, through to Wound Solutions and Plasma Surgical Ltd.
MLE holds 15 years of experience in designing for the highly specialised, regulatory controlled, safety-critical medical and healthcare market places. For medical device design and healthcare product development MLE designs 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. MLE understands these regulatory obligations.
The expertise of its strong engineering team spans analogue and digital design, including embedded systems, DSP, power supply technology, motor drives, instrumentation and software. Adopting a five-stage design process accompanied by a creative consultative approach to product development, MLE ensures intelligent, friendly and cost effective technology and product commercialisation for its customers.
