ISO 13485 medical device consultancy Australia-Wide

ISOsafe is a specialist medical device consultancy helping Australian manufacturers, sponsors and importers achieve and maintain ISO 13485 certification quickly, efficiently and with minimal disruption to day‑to‑day operations.

If you design, manufacture, distribute or sponsor medical devices in Australia, your ISO 13485 quality management system needs to do more than “pass an audit”. It must support TGA expectations, reduce risk, and give your team confidence that your devices are safe, effective and compliant.

ISOsafe partners with start‑ups, growing manufacturers and established multinationals to build, upgrade and streamline ISO 13485 systems tailored to the Australian and global regulatory landscape.

Call Us Now to discuss your current QMS, certification plans and regulatory obligations with an experienced ISO 13485 consultant. Receive a practical roadmap within 48 hours.

Why ISO 13485 matters in Australia

For medical device companies operating in Australia, ISO 13485 underpins your ability to demonstrate consistent design, manufacture and post‑market control of your products. It supports market access in Australia and overseas, strengthens clinical and commercial partnerships, and helps reduce adverse events and recalls.

A robust ISO 13485 quality management system also demonstrates to investors, notified bodies and regulators that you take patient safety, product performance and continuous improvement seriously.

ISO 13485 Certification:

• Supports Australian and international market access for medical devices and IVDs.

• Provides a structured, risk‑based framework for device design, manufacture and post‑market surveillance.

• Reduces nonconformities, complaints, CAPAs and costly rework.

• Builds trust with clinicians, healthcare providers and distributors.

ISOsafe ISO 13485 consultancy services

At ISOsafe, we focus exclusively on medical device and IVD quality and regulatory systems, with deep experience across Australian and international markets.

Services:

• ISO 13485 gap analysis and readiness assessments
  Identify gaps against ISO 13485:2016 and Australian regulatory expectations, with clear, prioritised recommendations and timelines.

• QMS design, implementation and remediation
  Design new quality management systems or remediate legacy systems, including procedures, templates, forms and records aligned to your product risks and lifecycle.

• ISO 13485 internal audits and supplier audits
  Plan and conduct internal audits, prepare your team for certification audits, and assess key suppliers to ISO 13485 and related requirements.

• Risk management and technical documentation support
  Integrate ISO 14971 risk management into your QMS, and align technical files, design dossiers and clinical evidence with your quality system.

• Training and ongoing support
  Deliver tailored training for management, quality, regulatory and operations teams, and provide ongoing advisory support before and after certification.

Who we work with

ISOsafe supports organisations across the medical technology ecosystem, including:

• Early‑stage MedTech start‑ups preparing for first‑in‑human or first market release

• Established device manufacturers upgrading from ISO 9001 to ISO 13485

• Australian sponsors and importers aligning quality systems with ISO 13485

• Digital health and software as a medical device (SaMD) companies

• Contract manufacturers producing components or finished devices for global markets

Each engagement is tailored to your device classification, markets, risk profile and internal resources.

Our ISO 13485 approach

Our approach is practical, collaborative and risk‑based. We focus on building systems that work in the real world, not shelfware that only appears during audits.

Key principles:

• Understand your products, processes and regulatory strategy

• Prioritise high‑risk areas and quick wins for early improvement

• Align QMS processes with existing workflows and tools where possible

• Provide clear documentation, templates and training for your team

• Prepare you thoroughly for certification and surveillance audits

Instead of copying generic procedures, we design and refine your ISO 13485 system so it is intuitive to use, easy to maintain and scalable as you grow.

Ready to simplify ISO 13485 certification?

Whether you are starting from scratch or optimising an existing quality management system, ISOsafe can guide you from initial gap analysis through to successful ISO 13485 certification and beyond. We work with teams across Australia, including Sydney, Melbourne, Brisbane, Adelaide, Perth and regional centres.