SAMD
In Australia, software-based medical devices fall under the TGA's medical device framework, with specific classification rules and a set of carve-outs (some software is excluded altogether, some exempt from ARTG inclusion but still regulated). Devices that are caught must be included on the ARTG via an Australian Sponsor.
At Taylored Consultancy Ltd, we make software compliance clear and stress-free. We help you work out whether and how your software is regulated, then guide you through classification, evidence and ARTG inclusion.
Clearing the path to market -
regulatory and quality expertise that gets your software safe, compliant, and ready for market.
The first step in Australia is working out whether your software is regulated at all. We assess it against the TGA's software-specific rules, exclusions and exemptions.
We determine the correct classification under the TGA's software classification rules, ensuring you follow the right pathway.
We help you put a compliant software development lifecycle and documentation in place.
We help you compile clinical evidence, leveraging comparable overseas approvals where the TGA accepts them.
We build your risk management file, including software and AI/ML risks.
We manage your application for inclusion on the ARTG.
A local Australian Sponsor is required to hold the ARTG entry. We help you put the right arrangement in place.
We help you implement a QMS to ISO 13485, the backbone of software medical device compliance.
Regulations can feel like a headache, but they don't have to be. We make sure you're covered, compliant, and ready to sell - without unnecessary delays or legal pitfalls.
EN 62304 / IEC 62304 - Medical device software lifecycle
IEC 82304-1 - Health software products
IEC 62366-1 - Usability / human factors engineering
ISO 14971 - Risk management for medical devices
ISO 13485 - Medical devices QMS
ISO/IEC 42001 - AI management systems
ISO 9001 - General quality management
