Your agile and dependable regulatory partner
“We assist medical device and IVD companies
achieve regulatory success and compliance in Australia”
– Gary Burgess, Director
Knowledgeable
Over 20 years’ experience in medical device regulatory affairs. 9 years within the TGA. Biomedical engineering background.
Responsive
Prompt, detailed advice and service you can rely on to make important decisions affecting your products, business, and patients.
Fearless
Delivers frank advice and prepared to defend you against the regulator (or your marketing team), when required.
Areas of expertise
Services offered
We provide advice and assistance to the therapeutic goods industry, with a focus on regulatory and quality requirements for medical devices (inc. IVDs) in Australia.
We can assist with a large variety of tasks and issues, including:
- Manufacturer certification & product registration with TGA, including:
– Conformity Assessment applications
– ARTG applications (inc. Manufacturer’s Evidence)
– TGA Export Only applications - Regulatory strategy development for successful market launch
- Responding to and communicating with the TGA, including pre-submission meetings, requests for further information (s41JA), and appealing initial decisions under s60 of the Act
- Delivering in-house training to your staff on medical device regulatory requirements and TGA processes
- Reviewing labels and instructions for use (IFU) for compliance with regulatory requirements
- Reviewing marketing material for compliance with local advertising regulations and relevant codes of practice
- Providing ad hoc ongoing regulatory support & advice
Let’s work together on your
next regulatory project
Contact us to arrange a confidential, no-obligation discussion
about your needs and how we may assist your business.