Founded in Sydney by Glenn Street, the practice has served Australian and international sponsors through every significant TGA reform of the past two decades.
With more than 20 years’ experience in the health sector, and over 17 years in the medical device regulatory and quality arena, Melanie brings a passion for the delivery of safe, innovative and effective healthcare. Having worked across a wide range of clinical fields, she applies that knowledge to suit the needs of varied clients and employers.
She has expertise in Class III device applications and associated level 2 audits (including devices with medicinal components and AIMDs), clinical literature reviews, marketing and consumer literature, and advice on regulatory requirements for companies in line with industry standards. She understands international regulations and has worked on the implementation of the transition from the EU MDD to MDR.
Melanie also submits prostheses list applications and assists with reimbursement coding to maximise market access and returns. She is a BSI ISO 13485 accredited internal auditor. Her risk management, project planning, and interpersonal skills help companies with the compliant and timely release of their products and growth in both the Australian and international healthcare markets.
Languages: English and German.
Glenn Street began his career as a registered nurse specialising in cardiology and mental health and has more than three decades of experience in Australian medical device regulation across government, industry and private consultancy. He joined the TGA in 1991, helping establish the ARTG and later contributed to the Electronic Lodgement Facility (ELF), including its system logic and industry engagement with the interface, and travelled across Australia with the TGA to support industry adoption.
Glenn subsequently joined the team responsible for developing the Electronic Device Application Program. His work involved collaboration with major medical device companies regarding data-entry requirements, which provided him with a comprehensive understanding of the Therapeutic Goods Act and its practical implications for the medical device industry. He later delivered national lectures on the DEAL system and its operation.
Glenn was part of a six-person team that received the Public Service Australia Day Award for achievement and innovation in 2003. He later served as Team Leader of the Device Application Section.
In 2004, Glenn joined MTAA as Science Officer, Medical Devices, where he delivered lectures on the application of Therapeutic Goods legislation and supported companies in resolving regulatory matters.
He has given evidence and supported NSW Parliamentary hearings into the use of retractable needles and other examined devices.
Glenn established his private consultancy in 2005. Today, he draws on extensive experience from within the regulatory system and direct industry engagement to provide practical, informed regulatory guidance to medical device companies.
Initial 30-minute consultations are complimentary. We will review your company’s needs, portfolio, and assess your next steps and requirements.