Martin A. Devitt Email & Phone Number

I am a medical practitioner, continuing to practice in emergency medicine. I have over 15 years experience in the medical devices field, both as a regulator and within the industry in Australia and internationally. I was previously the head of the clinical section in medical devices at the Therapeutic Goods Administration (TGA) in Australia. My role included the provision of high level advice on clinical considerations in the regulation of medical devices; participation on the TGA’s Medical Devices Expert Committee (MDEC) and Medical Device Incident Review Committee (MDIRC); the development of legislation and policy initiatives both nationally and internationally, including input into the workings of the Global Harmonisation Task Force (GHTF); participation as a member on a committee of Standards Australia; and the auditing of quality management systems to ISO 13485. I have also held senior positions within multinational medical device companies, including COOK Medical and Covidien, providing advice on pre- and post-market safety, quality, performance, and marketing issues pertaining to the manufacture and supply of medical devices globally. I founded Lifecycle Medical and act as the company’s Managing Director. With experience from both the regulator and the industry, my expertise encompasses clinical and regulatory input into all aspects of medical device research and development, manufacturing, and commercialisation, including clinical trials, clinical evidence, and post-marketing issues; health technology assessment of medical devices for reimbursement; and quality management system auditing to ISO 13485 and clinical trial auditing to GCP. I have also successfully completed the Company Directors Course through the Australian Institute of Company Directors (AICD) and I have been a Director on a number of Boards. I am therefore also able to provide corporate advisory services to companies pursuing the commercialisation of medical devices.

Listed skills include Medical Devices, Clinical Research, Clinical Trials, Medicine, and 14 others.

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  Consultant Medical Director

  Resmed

  Sydney, Nsw, Au