Regulatory Affars Medical Devices Consulting Blog
Monitoring the changes and keeping up with the medical device legislation, standards, and guidelines set by the Therapeutic Goods Administration and other regulating agencies is challenging for small and medium scale medical device manufacturers. However, to be able to market products and reach target markets, it is important that these manufacturers comply with all the regulations.
Vicki Partridge’s high quality medical device consulting services are designed to help medical device manufacturers through all facits of product design, development, approval, and ongoing after-market activities. Our goal is to provide manufacturers with a clear understanding of the requirements needed throughout the product life cycle and help you with the regulatory affairs medical devices registration.
TGA Medical Device Registration
TGA device registration is a legal requirement for supplying a medical device in Australia. Your device must be included in…
How to Structure Effective Clinical Evaluation Reports
Clinical evaluation reports are a core part of technical documentation required under TGA regulations. Based on sufficient clinical evidence, these…
EU MDR vs. FDA: Key Differences in Medical Device Regulations
Managing the regulatory landscape of medical devices requires a clear understanding of the EU MDR vs FDA frameworks. Both systems…
A Breakdown of the New EU Medical Device Regulations
The new EU medical device regulations (MDR) introduced significant changes to the regulatory framework. The MDR, officially applied on May…
European Authorised Representative for Medical Device Companies
A European Authorised Representative (EAR) for medical device companies is essential for companies based outside the European Union (EU) aiming…
Biological Consultant in Australia
Having limited knowledge regarding the process of having your biological products and therapeutic goods approved for distribution in the Australian…
Medical Equipment Suppliers in USA
Over the years, the medical equipment industry in Australia has never ceased creating opportunities for medical equipment suppliers and exporters…
Clinical Trial Regulatory Specialist
Vicki Partridge is a trusted clinical trial regulatory specialist in Australia. With decades of strategic development, global compliance, and therapeutic…
Finding The Right Medical Device Marketing Consulting
According to researches, the medical device industry has grown at an unprecedented rate. This is because many medical device companies…