Rod Lane’s new role involves programme managing the diverse range of development projects that MLE undertakes, ensuring that clients’ requirements are accurately captured and their expectations are met or exceeded. Previously Head of New Product Development for Odstock Medical Ltd, Rod Lane comments, “What I bring is a sound understanding of product development for the medical market, with excellent knowledge of the standards and regulatory requirements that have to be met for CE mark and FDA approvals.”
Jeff Pickering is an engineer with many years of experience, having held the position as Chief Design Engineer within the Navigation Systems Group of Marconi Radar. More recently, Jeff was the Education Manager at the Institute of Health Engineering and Estate Management. Working closely with Rod Lane, Jeff provides a key contact liaising with both new and existing customers to ensure smooth lines of communication.
“Following our on-going success in the co-development of innovative medical devices with a number of partner companies, we are very pleased to welcome Rod and Jeff to our growing medical and healthcare team,” adds Nigel Harley, Director of Strategic Development at MLE. “Both are excellent additions, further enriching MLE’s proven expertise in medical electronic product design and development that would require typically FDA 510k approval, ISO13485 and also the UK/European medical device directive.”
ABOUT MLE Creative Electronics:
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.
