Medical Device Consulting Services
Vicki Partridge is a highly experienced Australian-based Regulatory Affairs Consultant representing manufacturers and sponsors who import and export Therapeutic Goods from and to Australia via the European, United States, Asian and New Zealand markets.
Comprehensive Medical Device Regulatory Support
Vicki has an excellent track record in medical device consulting, delivering professional services to her clients by taking care of the entire regulatory process required to supply medical devices in the Australia market place and managing the ongoing compliance of these devices throughout their lifecycle. Vicki is able to provide both a unique medical device quality consulting services as well as representation as an Agent. She is able to provide considerable value and benefit by either enhancing the existing knowledge base of your regulatory affairs unit or through streamlining the path of your Australia medical device regulations to market such as:
- facilitation of registration of your company as a potential supplier of medical devices to the Australian market;
- co-ordinating pre-submission discussions with the Therapeutic Goods Administration (TGA);
- 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 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;
- reviewing advertising or promotional material to ensure compliance with the Advertising Code;
- preparing and lodging documentation for CE marking of medical devices; and
- providing customized regulatory and medical device compliance training (on-site).