MEDICAL DEVICE ADVICE
Regulatory Consulting Australia
EXPERIENCED. EFFICIENT. TRANSPARENT.
Medical Device Advice (MDA) specialises in assisting distributors of medical devices in Australia to obtain TGA registration and reimbursement listing for their products and to comply with their regulatory responsibilities.
MDA also assists Australian manufacturers in the development of medical devices for Australian and overseas markets. Such assistance includes regulatory planning, submission writing and preparation, risk management activities and training.
Whether you are new to the medical device regulatory landscape, or an established company requiring an extra pair of regulatory hands to help with new projects or staff leave, contact MDA to discuss how we can assist.
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FREE INITIAL CONSULTATION.
EXPERIENCED.
Bruce Gregory, director and principal consultant of MDA, has over 35 years in the biotechnology and medical devices industries, the last 10 years of which have been in consulting.
During this time, he has worked with over 150 Australian medical device distributors and obtained over 500 TGA device registrations.
He has worked within the product development environment and has detailed knowledge and experience of the medical device design, testing and certification processes.
He experience covers products ranging from Class I to Class III, and includes products such as reusable surgical instruments, in vitro diagnostic (IVD) devices, implantable joint prostheses and active implantable devices.
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Click here to view Bruce's resume.
EFFICIENT.
Experience means projects are run smoothly and efficiently, thus ensuring the fasted path to regulatory approval and market release.
TGA and other fees are kept as low as possible by grouping similar products under single registrations and, where possible, requesting fee reductions in certain circumstances. TGA and reimbursement applications can be submitted in parallel to ensure products can be released to market ASAP.
In most cases Bruce deals directly with manufacturers in order to gather the necessary documentation for successful registrations.
TRANSPARENT.
Full transparency is provided throughout projects.
Cost and time estimates, including government fees and consulting costs, are provided for all projects. Due to the many variables involved in product registrations, fixed quotes are not provided.
Clients are kept abreast of the progress of all projects and remain in control of the quantity of work performed.
Detailed timesheets of all work are maintained and provided with invoices to the client at the end of each month.