Medical Device Solutions, Built on a Regulated Foundation
akunah develops and manufactures software as a medical device under a certified ISO 13485 quality management system, with regulatory clearance from the TGA and FDA and MDSAP certification. From AI-powered surgical planning to regulatory support, we help bring safe, compliant medical technology to clinicians worldwide.
akunah reflect
Complex shoulder procedures require precise pre-operative planning to help surgeons visualise anatomy and determine the optimal surgical approach.
akunah reflect is a specialised shoulder planning platform that uses AI-powered 3D modelling to support surgical preparation for primary, revision, replacement, and instability cases, giving surgeons the flexibility to evaluate anatomy and plan procedures with confidence.
akunah regulatory
Bringing a medical device to market requires navigating complex regulatory pathways across multiple jurisdictions — a process that can slow innovation and strain internal teams.
akunah regulatory offers hands-on regulatory and quality support built on our own experience taking software as a medical device through TGA, FDA, ISO 13485, and MDSAP certification. We help medtech companies establish compliant quality management systems, prepare regulatory submissions, and maintain post-market compliance across international markets.
