A digital health startup had a proven clinical product and a clear market — but no path through TGA registration without specialist guidance.
A Perth digital health startup had built a clinical decision support tool using machine learning to detect early signs of sepsis in ICU patients. The clinical evidence was strong. To sell to public hospitals in Australia, they needed TGA registration as a Class IIa medical device software. Neither the founding team nor their three engineers had any regulatory experience.
Our fractional CTO had prior experience navigating TGA’s Software as a Medical Device framework and understood IEC 62304 and IEC 62366 requirements. We began with a gap analysis and designed three parallel workstreams: regulatory documentation, technical remediation, and hospital pilot programme design.
Technical work covered: implementing a formal configuration management system, establishing software validation protocols, and documenting the ML model’s clinical evidence and limitations in line with TGA guidance on AI/ML-based devices. We also negotiated the three hospital pilot agreements, structuring them to generate the post-market surveillance data TGA would require for ongoing registration.
TGA registration was achieved at month seven. The seed extension of $1.8M closed on the back of the TGA registration and signed pilot agreements. All three hospital pilots commenced within 60 days of registration.
Understanding regulatory requirements early and building them into your development process — rather than retrofitting them — is the difference between a 7-month pathway and a 2-year one.
Book a free call with a CTO who has 27 years of hands-on experience — and a track record of measurable outcomes.