For professional advice and expertise, call us on 0439 782 869 | 07 3806 1297
Medical Devices
As an accredited TGA agent Quality Matters Safety Matters Pty Ltd is committed to ensuring that:
- All sponsors are fully aware of their obligations
- All sponsors have the resources on hand to realise their obligations
- All products are fit for purpose and correctly included in the ARTG and
- Any issues, concerns or problems are dealt with promptly and professionally
Our Clients
Our clients have more than 200 different medical devices included on the ARTG, most of these are class I devices, and many are formulated devices.
We also provide assistance for:
- Class I m and s
- Class IIa and IIb
Technical dossiers prepared by Quality Matters Safety Matters Pty Ltd have been used by our clients for:
- International compliance and registration of their products in a range of jurisdictions, including EU and Asia
- Gaining and maintaining key and lucrative contracts in the international arena
- Demonstrating due diligence to regulatory authorities
IVD
Quality Matters Safety Matters Pty Ltd may be able to assist you in ensuring that your IVD are compliant and correctly included in the ARTG.
We have experience with:
- A wide range of laboratory reagents
- A number of different bio-assays
- Enzymes and enzymology
- Industrial and commercial microbiology
ISO 13485
We can assist you with your ISO 13485 quality systems:
- Documentation
- Risk assessments & essential principles
- Auditing and trouble shooting
Opening Hours
- Mon - Fri
- -
- Sat - Sun
- Closed