Vicki Partridge Pty Ltd
Guaranteed Medical Device Regulation Compliance

When it comes to acquiring QMS Certifications for the production and distribution of medical devices, OEMs and manufacturers must follow stringent compliance and regulatory laws or risk operations coming to a standstill. An expert in the Medical Device Regulations sector in Australia, Vicki Partridge believes that the new Medical Device Regulations falling into effect across Europe in May 2020 will lead to an increase in the number of manufacturers seeking Certificates under the upcoming EU Medical Device Regulations. However, the shortage of approved Notified Bodies that can levy the new medical device regulatory certificates can seriously hamper the successful transition of a medical device manufacturer’s operations to be adherent to the new norms. And, with Brexit now in motion, the absence of a formal trade agreement between the UK and other European regions is another major issue that is set to disrupt the medical device markets. However, if a QMS has been certified under the new regulations, it provides an easy transition into the Australian and New Zealand markets.

With more than 15 years of experience working in the Medical Devices Branch of the Australian Therapeutic Goods Administration (TGA), Vicki Partridge is well placed to assist these manufacturers in compensating for the deficit of product distribution venues. On behalf of these medical device manufacturers, Vicki monitors the product development closely and liaises with the TGA to allow the manufacturers to access the Australian and New Zealand markets. “Though we are in Australia, most of our clients are located in Asia, Europe, Canada, and the US; I have extensive knowledge of the regulatory requirements in each of these markets,” explains Vicki Partridge, Managing Director and CEO of Vicki Partridge Pty Ltd.

Through her personalized consulting service, Vicki has represented over 50 clients globally, and the company has garnered a 100 percent success rate in obtaining all the required registrations and CA Certificates for clients to conduct business in Australia and New Zealand. Vicki, to successfully aid the manufacturers set up shop, conducts discussions with them to fully understand their business value and history. As maintaining total transparency and avoiding discrepancies is essential for proper registration application submission, Vicki, in some instances, advises prospective clients to refrain from investing their time and money in lodging an application for a product, if and when the products has very little chance of being approved.

While we are in Australia, our clients are located mostly in Asia, Europe, Canada, and the US, and I have extensive knowledge of the regulatory requirements in each of these markets

“We advise potential customers to save their money and not to proceed when the manufacturer’s documentation is inadequate and/or the QMS Certification is not appropriate or if the application is likely to be rejected,” comments Leigh Partridge, Manager at Vicki Partridge Pty Ltd. The collective experience brought to the table by Vicki and team often helps these companies in realizing that they do not have the necessary certifications or quality of documentation required to procure approval for inclusion from the TGA or other regulatory bodies.

To successfully facilitate the registration of products for medical device manufacturers, Vicki thoroughly examines all their existing documentation. Upon completion, a comprehensive list of all of the documentation and certifications required before an application submission is created. Vicki then oversees and co-ordinates the pre-submission Conformity Assessment discussions with the TGA, as the chief consultant of her firm. The CEO personally prepares the submissions for SAS, Prosthesis, and sponsorship. “I look after every client personally; I do not hand over any project to younger affiliates, and that’s one of the reasons why we have been so successful”, explains Vicki.

In addition, Vicki also reviews previous application submissions and conducts audits to assist clients with improving the quality of information for any post-market activity. On successful registration, the medical device regulations consulting firm matches manufacturers with appropriate Australian Distributors. Besides assisting manufacturers in entering the Australian and New Zealand medical device market, Vicki Partridge Pty Ltd offers a similar service to pharmaceutical and medical device companies seeking to conduct their clinical trials in the region.

Being selective and limiting her workload to no more than three major projects at a time, Vicki can deliver highly personalized service with great skill and experience across multiple medical device types to all of her clients. In one such case, Vicki represented a major biological product manufacturer from the United States and successfully had ten of their products included on the ARTG. These products were the first to successfully navigate TGA’s new online application registration and evaluation system.

Going forward, Vicki Partridge Pty Ltd is gearing up to undertake a major clinical trial in Australia for a new product developed by one of its established customers. To keep abreast of the latest information on the many global medical devices regulatory boards, Vicki Partridge attends relevant international conferences and visits existing clients every year to understand the changes in local regulations and market conditions.