Advisory · Intelligence · Education
Build the regulatory posture regulators expect — before they ask.
Saolyn helps medical device manufacturers, quality leaders and strategic investors see what's coming, design the systems that get them through, and lift their teams to operate at that bar. Advisory, intelligence reports, and applied education — from one place.
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Advisory Services
Audit, quality systems, CAPA, supplier risk and AI integration — built around ISO 13485, MDSAP, FDA and TGA. For manufacturers, importers and developers who need compliance to move as fast as the rest of the business.
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Intelligence Reports
The MedTech Intelligence Reports — a quarterly strategic series examining the geopolitical, regulatory and exponential forces reshaping medical technology.
Read the reportsEducation
Applied Education
Practical, operator-grade training that lifts quality and regulatory teams to the standard the work demands. Coming soon.
Register interestRegulatory expectations rise as timelines compress.
The teams that scale are the ones that build the posture before a regulator asks them to prove it. Saolyn brings operator-grade systems and outside-in intelligence to that problem — so compliance moves at the speed of the business, not against it.
How we work
From checklists to strategic compliance
01
Assess
Gap analysis and readiness review against ISO 13485, MDSAP, FDA and TGA — an honest read of where you stand.
02
Design
Architect the quality and compliance systems that fit your business and meet the standard, not a generic template.
03
Implement
Build it in: documentation, CAPA, supplier controls and low-code automation that hold up under audit.
04
Sustain
Embedded or fractional oversight and applied training so the system stays live after we step back.
Q1 2026 · MedTech Intelligence Reports
The State of AI in Medical Devices 2026
A structural read of an industry at the point of fracture — mapped through three frameworks: the Regulatory Trilemma, the Approval–Adoption Abyss, and the Algorithm Arms Race. Decision intelligence for the boards, investors, regulators and operators shipping AI-enabled devices.
Founded in Brisbane by Ross Prior. Ten-plus years across engineering, quality assurance, regulatory affairs and audit in medical devices and advanced manufacturing — now extended into a strategic intelligence practice serving the same industry from the outside in.
About Saolyn