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 that bar. Advisory, intelligence reports and applied education — plus the A‑SIM audit simulator and PMS Sentinel surveillance — from one place.
Advisory Services
Audit, quality systems, CAPA, supplier risk and AI integration — built around ISO 13485, MDSAP, FDA and TGA. For teams who need compliance to move as fast as the rest of the business.
Explore services IntelligenceIntelligence Reports
The MedTech Intelligence Reports — a quarterly strategic series on the geopolitical, regulatory and exponential forces reshaping medical technology.
Read the reports EducationApplied Education
Practical, operator-grade training that lifts quality and regulatory teams to the standard the work demands. Coming soon.
Register interestEverything Saolyn, in one place
Read the executive summaries, buy the full reports, take a course, register for the EEC cohort, try the audit simulator, and explore live surveillance cards — advisory, intelligence and applied education, together.
Intelligence Reports
PDFDownload the executive summary; unlock the full report when you need the depth.
Browse reportsApplied Education
Coming soonOperator-grade courses on post-market surveillance, ISO 13485 auditing and regulatory practice. Launching soon.
Register interestEEC
RegisterCohort-based executive education — applied, small-group and outcomes-focused for quality & regulatory leaders.
Register interestA‑SIM Audit Simulator
TrialPractise a live audit against realistic scenarios and get scored on how you reason, not just what you recall.
Try A‑SIMPMS Sentinel
PublicAI-native post-market surveillance. Explore live device-performance cards with full source transparency.
View device cardsAdvisory
BookFractional and embedded quality & regulatory oversight — assess, design, implement, sustain.
Explore servicesFrom checklists to strategic compliance
The teams that scale build the posture before a regulator asks them to prove it. We bring operator-grade systems and outside-in intelligence to that problem.
Assess
Gap analysis and readiness review against ISO 13485, MDSAP, FDA and TGA — an honest read of where you stand.
Design
Architect the quality and compliance systems that fit your business and meet the standard, not a generic template.
Implement
Build it in: documentation, CAPA, supplier controls and low-code automation that hold up under audit.
Sustain
Embedded or fractional oversight and applied training so the system stays live after we step back.
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.
Ross Prior, Author — Saolyn · Kelly Coverdale, Co-Author — Cover Biomedical
MedTech Intelligence
The State of AI in Medical Devices
2026
- Full report
- 49 pp
- Executive summary
- 5 pp
- Format
“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