Medical Devices - Quality Matters Safety Matters

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

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

Quality Matters Safety Matters Pty Ltd

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

Quality management consultancy services tailored to your specific needs.

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