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.

Quality Matters Safety Matters Pty Ltd

Contact: 0439 782 869 talktous@qualitymatterssafetymatters.com.au

Quality management consultancy services tailored to your specific needs.