Jonathan Lee is the President of Medical Device Consulting Solutions International serving clients both within and outside the US.

An early career in Class III Medical Devices in Australia and now located in the USA, Mr. Lee has extensive personal experience with FDA from product submission, product amendment, site audit, field action, to end of product life. This experience, gained over 35 years, involved working with both US based and out of US (OUS) based organizations.

A multiple patent holder, Mr. Lee’s prior roles include VP R&D at Cardiac Control Systems, Vice President Quality, Regulatory & Clinical affairs at Medtronic.

In addition, his consulting roles include supporting: implantable bio stimulation telemetry systems, implantable heart sub-system, catheter defibrillation systems, surgical tools, vertebral stiffness measuring systems, respiratory interfaces, cardiac catheter development, medical device process V&V, quality system development & implementation, clinical study management and product clearances & approvals.

His success has been shared through participation in webinars, seminars, and presentations including being an invited speaker to the Association of Food and Drug Officials (AFDO) and conference participation in compliance symposia at Harvard University and serving as an instructor on Quality Systems at the University of Southern California School of Pharmacy Master’s Degree Program.

Mr. Lee holds an Electrical Engineering (Biomedical) BE degree from the University of NSW in Australia with post graduate work in Computer Studies at the same University.