About
About Saolyn
Saolyn was founded in Brisbane by Ross Prior after more than a decade inside the engineering, quality, regulatory and audit functions of medical-device and advanced-manufacturing businesses — the kind of calls that don't make it into a textbook but quietly decide whether your next submission lands.
We specialise in quality, compliance and applied intelligence for regulated industries, with a particular focus on medical devices and advanced manufacturing. We help businesses navigate ISO 13485, MDSAP, FDA and TGA requirements — from audit readiness and CAPA management through to technical documentation and market approvals — with practical, results-driven work that aligns with commercial goals.
Our mission is to bridge the gap between compliance and commercial success. Whether you're launching a new device, expanding into global markets, or streamlining manufacturing, we partner with you to build systems that scale — safely, reliably and compliantly. The aim is to move you from checklists to strategic compliance with confidence.
Saolyn is deliberately practitioner-led rather than a large generalist consultancy: the person advising you has carried the consequence of these decisions inside regulated businesses. Alongside the advisory practice, we publish the MedTech Signals report series and build a small family of tools — applied education, the A‑SIM audit simulator, and PMS Sentinel post-market surveillance — that extend the same operator-grade thinking into products a team can use directly.
- 10+ yrs
- in medtech RA / QA
- 30+
- submissions & audits supported
- 4
- active client engagements
What we do
One practice, five ways to work with us
From hands-on advisory through to self-serve intelligence and tools — pick the depth that fits where you are.
Advisory
Audit, QMS design, CAPA, supplier risk and AI integration — built around ISO 13485, MDSAP, FDA and TGA.
Learn moreMedTech Signals
A quarterly strategic-intelligence report series read by boards, executives and investors. Executive summary and full report, as a secure PDF.
Learn moreApplied Education
Self-paced courses and the Executive Education Cohort (EEC) for people in regulated roles.
Learn moreA‑SIM
The Saolyn Audit Simulator — practise a live audit against realistic scenarios and get scored on how you reason.
Learn morePMS Sentinel
AI-native post-market surveillance — live device-performance cards with full source transparency.
Learn more“We move regulated businesses from checklists to strategic compliance — and give their leaders a clear read on where the industry is going.”
Ross Prior · Founder, Saolyn
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