About Vicki Partridge
About
Vicki Partridge has more than 30 years working experience in the fields of Biological Research and Australia medical device regulations, including 15 years with the Therapeutic Goods Administration (TGA), where she:
- worked with and interpreted the legislative and regulative requirements for the supply of therapeutic goods in Australia;
- consulted with members of the Australian industry’s peek bodies and World Health
Organisation (WHO); - evaluated submissions from industry and made determinations as to their compliance with the relevant legislation; and
- conducted internal audits of the TGA’s Quality Management Program.
In 2012, Vicki left the TGA and set up a consulting business through which she has consulted to companies throughout the world and conducted in-house medical device regulatory training and workshops both in Australia and the US.
Vicki is a highly experienced regulatory consultants Australia representing medical device manufacturers and therapeutic goods administration agent (TGA sponsor) who import and export Therapeutic Goods from and to Australia via the European, United States, Asian and New Zealand markets.
Vicki has an excellent track record as Regulatory Consultants Australia and in delivering professional services to her clients by taking care of the entire regulatory process required to supply medical devices to the Australian market and managing the ongoing compliance of these devices throughout their lifecycle.
Her expertise also extends to dental products regulatory consulting. She ensures that dental devices meet the necessary regulations and standards for market approval.
Vicki is able to provide both a medical equipment consultant as well as a representation as an Agent. She can provide considerable value and benefit by either enhancing the existing knowledge base of your regulatory affairs medical devices or unit or through streamlining the path of your medical devices to market, such as:
- facilitation of registration of your company as a potential supplier of medical devices to the Australian market;
- coordinating pre-submission discussions with the Therapeutic Goods Administration (TGA) and help you understand TGA medical device regulations;
- preparing submissions for SAS;
- preparing submissions for Prosthesis List;
- preparing submissions for sponsor/sponsor transfer of existing inclusions;
- assessing Manufacturer’s Certification as issued by European Union Notified Bodies;
- preparing documentation in response to requests made by the TGA, specifically Sections 41 JA, 41FD and 41FN;
- preparing documentation relevant to Schedule 3, of Therapeutic Goods (Medical Devices) Regulations 2002;
- preparing and reviewing documentation to demonstrate compliance with Essential Principles;
- preparing applications and assisting with the device classification and GMDN code determination;
- reviewing new device applications to identify any issues or potential improvements to ensure successful approval;
- reviewing previous submissions and conducting audits to assist with improving the quality of information for any post-market activity;
- conducting supplier audits;
- reviewing advertising or promotional material to ensure compliance with the Advertising Code;
- preparing and lodging documentation for CE marking; and
- providing customised regulatory training on-site.
Vicki acts as an Australian agent for US and European medical device exporters, undertaking any recall actions required by the TGA.
Commitment to Client Success
When selecting among regulatory affairs consultants in Australia, opt for someone who is not only knowledgeable but also competent. Vicki works closely with her clients to understand their products, target markets, and regulatory challenges.
She identifies the most effective pathway for meeting current Therapeutic Goods Administration (TGA) requirements while anticipating potential changes that could affect future compliance. Her approach is practical, thorough, and shaped by more than three decades of hands-on experience.
Clear communication is a key part of her work. Clients know what to expect at each stage of the process, from preparing applications and responding to TGA requests to managing ongoing compliance once products are on the market. As one of the reputable regulatory affairs consultants in Australia, Vicki can explain complex requirements in plain language, helping teams make informed decisions and avoid costly setbacks.
Vicki’s support extends beyond technical submissions. She works with businesses to plan regulatory activities so they align with broader objectives. This helps teams to focus on innovation, marketing, and distribution.
With Vicki as your medical equipment consultant, she can help shorten approval timelines, strengthen compliance systems, and improve readiness for audits. Her consistent results and straightforward, solutions-focused style have earned the trust of medical device manufacturers, sponsors, and distributors in Australia and internationally.
Expert in Implantable Medical Device Compliance
As an implantable regulatory consultant in Australia, Vicki Partridge supports sponsors and manufacturers working with higher-risk devices that demand careful regulatory planning. Implantable medical devices attract stricter scrutiny due to their long-term contact with the body, potential clinical risks, and the level of evidence required to demonstrate safety and performance.
In Australia, these devices may require stronger conformity assessment pathways, detailed technical documentation, and clear alignment with Essential Principles before ARTG inclusion can proceed. TGA guidance also makes clear that clinical evidence must be sufficient for the device and its intended purpose.
Expertise in Australian & Global Regulations
With experience as a medical device regulatory consultant, Vicki Partridge helps clients address Australian requirements while keeping global market expectations in view. That includes support for classification strategy, evidence planning, regulatory submissions, and post-market obligations for implantable devices.
This level of support matters because implantable products often involve more complex review pathways, patient information obligations, and closer monitoring once supplied. TGA guidance for implantable devices highlights the importance of lawful supply, ongoing compliance, and accurate supporting information throughout the product lifecycle. For businesses seeking an implantable regulatory consultant in Australia, this added expertise can help reduce uncertainty and strengthen regulatory readiness
Associates
Vicki maintains a network of professional associates who provide specialist advice in areas such as medicines, pharmaceuticals, Clinical Trials, Statistical Analysis, and Biostatistics.
We take care of all your MEDICAL DEVICE REGULATION needs.