Provides the following type capabilities, either in-house or via strategic partnerships with other recognised medical device service providers.
Quality management system implementation in accordance with ISO 13485
Lifecycle Medical has expanded its services following the addition of new in-house expertise. Lifecycle Medical's services cover the planning, development, approval, supply and commercialisation activities of medical devices, including in vitro diagnostic devices (IVDDs) and software as a medical device (SaMD).
The additional in-house expertise within Lifecycle Medical includes the following:
- Australian sponsor responsibilities and collaboration with key Australian distributors.
- Software as a Medical Device expertise including:
- Access to an internationally recognised ISO 13485 and ISO 27001 software platform that is compliant to regulatory requirements across numerous jurisdictions.
- Experience in implementing IEC 62304 & IEC 82304.
- Medical device cyber security.
- Commercialisation expertise including:
- Intellectual property strategy and management.
- Market assessment and business model development.
- Investment fund-raising strategy and pitch preparation.
This additional in-house expertise adds to Lifecycle Medical's track record of success in numerous jurisdictions for a decade.
Do Great Work
With Great People
Dr Martin A. Devitt BMed GAICD
Martin is a registered medical practitioner who continues to practice in emergency medicine. He has over fifteen years experience in the medical devices field, both as a regulator and within the industry in Australia and internationally.
Martin was previously the head of the clinical section in medical devices at the Therapeutic Goods Administration (TGA) in Australia, a statutory body of the Australian Government that regulates the supply of therapeutic goods (medical devices, medicines, etc.) in Australia. His 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.
He has also held senior positions within multinational medical device companies, including COOK Medical and Covidien. In these positions, he provided high-level clinical advice on pre- and post-market safety, quality, performance, and marketing issues pertaining to the manufacture and supply of medical devices globally.
Martin founded Lifecycle Medical and is the company's Managing Director. He brings medical devices experience from both the regulator and the industry, and his 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 ICH GCP.
Martin has also successfully completed the Company Directors Course (CDC) through the Australian Institute of Company Directors (AICD) and has been a Director on a number of Boards. He is therefore also able to provide corporate advisory services to companies pursuing the commercialisation of medical devices.
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Tabrizi SN, Stevens MP, Khan ZA, Chow C, Devitt MA, Garland SM. Comparison of PapType to Digene Hybrid Capture 2, Roche linear array, and Amplicor for detection of high-risk human papillomavirus genotypes in women with previous abnormal pap smears. J Clin Microbiol. 2012 Aug;50(8):2796-8. doi: 10.1128/JCM.01064-12. Epub 2012 May 30. PMID: 22649012; PMCID: PMC3421518.
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Devitt M, Ramanan D, Armitstead J, Zhu X, Mackie H. Usability evaluation of a novel compact pneumatic compression device for the treatment of lymphoedema: Pilot study. Phlebology. 2022 Sep;37(8):564-571. doi: 10.1177/02683555221096298. Epub 2022 May 3. PMID: 35503339; PMCID: PMC9446425.