Services

Vicki Partridge is one of the country’s most sought after medical compliance consultant, catering for the needs of medical device manufacturers and distributors in the United States, Europe, Asia, Australia, and New Zealand. Our services include the provision of regulatory affairs consultation, medical device regulation, and representation for medical devices, biologicals, and pharmaceuticals.

We deliver professional and reliable medical device consulting services to our client base. We take care of the whole regulatory process needed to supply medical devices to the Australian market and manage the entire on-going compliance of such devices.

We have developed many medical device compliance training courses and workshops in Asia, Europe, the United States and Australia. Our workshops include Manufacturer’s Evidence, Medical Device Classification, Documentation, Declarations of Conformity, Procedure Packs and Systems, and The Role of a Sponsor.

Vicki Partridge Pty Ltd provides pre-audit assessment services where we provide helpful advice to companies in preparation for a full TGA audit. We ensure that any deficiencies arre identified and rectified before the audit takes place, speeding up the approval process significantly.

Vicki Partridge Pty Ltd acts as an agent/Sponsor for international companies that need local representation in Australia and New Zealand. We are available 24/7 to liaise with the TGA and work on any recall issues.

We have a strong team of clinical trials specialists who can undertake and manage all aspects of Clinical Trials undertaken in Australia.

We can manage all the requirements of the Department of Health Prosthesis List Management System (PLMS) to enable your product to be included on the Prosthesis List to enable reimbursement of the agreed amount for each device sold in Australia.