Saolyn

Services

Quality systems and applied intelligence for regulated medtech

Saolyn supports organisations in regulated and technical environments with expert-led, systems-based services — built around ISO 13485, ISO 9001, MDSAP, FDA and TGA. From audit and QMS design through to AI integration, we deliver structured work that aligns with your standards, supports your people, and scales with the business. We work with manufacturers, importers and developers who need compliance to move as fast as the rest of the company.

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Audit & Advisory

Independent, systems-aligned audit services across regulated sectors, supporting both certification and internal-improvement objectives.

  • Internal audits aligned to ISO 13485 and ISO 9001
  • Readiness and gap analysis for certification or regulatory compliance
  • Audit preparation for surveillance and recertification audits
  • Corrective-action review and remediation planning
  • Customised audit frameworks and risk-based scoping tools

System Design & Optimisation

We design, optimise or remediate operational and compliance systems to meet international standards, customer expectations and internal objectives.

  • Quality Management System (QMS) architecture and design
  • Process mapping, SOP development and documentation control
  • Policy alignment with ISO, TGA or client-specific requirements
  • Low-code automation for traceability, efficiency and oversight

Compliance & Documentation

We develop, maintain and improve operational compliance systems and controlled documentation in alignment with regulatory and standards-based requirements.

  • Technical-file development and structured document control
  • Risk registers, issue tracking and audit-trail design
  • CAPA — investigation, planning, effectiveness review and closure
  • Root-cause-analysis facilitation (5 Whys, Fishbone, Pareto)
  • SOP and work-instruction drafting across teams and functions
  • Supplier-approval and quality-assurance workflows

Fractional & Embedded Advisory

Fractional or embedded quality and compliance advisory — a senior pair of hands inside the building, without a full-time hire.

  • Interim or ongoing QMS leadership and governance
  • Internal-auditor or quality-advisor on-call services
  • Team coaching and compliance briefings
  • Oversight across multiple projects or product streams
  • Planning and facilitation of ISO-compliant management reviews

Supplier Risk Management

We help clients manage third-party and internal supplier risk through targeted, standards-based audit programmes and supplier-performance systems.

  • First-party (internal supplier) audit programmes
  • Third-party supplier audits aligned to ISO 13485, ISO 9001 and GMP
  • Risk-based supplier categorisation, scoring and performance tracking
  • Industry-specific audit-checklist development and delivery
  • CAPA support, audit documentation and regulator-ready reports

AI Integration & Applied Intelligence

We help organisations introduce AI and automation into operational, compliance and reporting workflows — safely, strategically and with governance built in.

  • AI-readiness assessments and risk evaluations
  • Use-case development and implementation planning
  • Integration of AI tools into existing platforms
  • Low-code workflow automation for audit, documentation and tasks
  • AI governance, responsible-use policy creation and staff enablement

Compliance that moves as fast as the business

Tell us where you're trying to get to. Discovery calls are 30 minutes, free, and useful even if we don't end up working together.

Book a discovery call