Quality Matters Safety Matters Pty Ltd acts as an accredited TGA agent for more than 50 different sponsors of medicines and medical devices in Australia.
We aim to ensure 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 have more than 200 different devices included on the ARTG, most of these are class I devices, and many are formulated devices.
We do however also provide assistance in including
- 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
Contact us talktous@qualitymatterssafetymatters.com.au for obligation free advice and/or a quote.
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
Contact us talktous@qualitymatterssafetymatters.com.au for obligation free advice and/or a quote.
ISO 13485
We can assist you with your ISO 13485 quality systems
- Documentation
- Risk assessments & Essential Principles
- Auditing and trouble shooting
Contact us talktous@qualitymatterssafetymatters.com.au for obligation free advice and/or a quote.