Enter markets. Pass audits.Prove Device Quality.
Going it alone takes most businesses 6 months. Our clients certify in as little as 4–8 weeks.
ISO 13485 is the medical-device industry's non-negotiable quality standard, expected by the TGA, FDA and European MDR, and every hospital procurement team. Done-for-you, fixed fee.
- No hidden costs, ever
- Dedicated Australian consultant
- Quick quote in 24 hours
Part of the global IMSM network
90,000+
active device entries on the ARTG
100%
certification success rate
Class I–III
every TGA risk class supported
60+
countries recognise 13485 as baseline
Where does your device sit on the TGA risk ladder?
ISO 13485 is the baseline for every class, but the evidence bar rises sharply as risk increases.
Class I, Low risk
Non-invasive or transient use with a self-assessment path in Australia, bandages, wheelchairs, reusable surgical instruments.
Class IIa, Low-medium
Short-term invasive or active devices requiring conformity assessment, hearing aids, infusion sets, contact lenses, dental fillings.
Class IIb, Medium-high
Long-term invasive or energy-emitting devices needing deeper scrutiny, ventilators, surgical lasers, dialysis equipment.
Class III, Highest risk
Life-supporting or implantable devices needing full conformity assessment, pacemakers, heart valves, spinal implants, SaMD decision systems.
Tell us your situation and headcount, we'll scope your fixed fee within 24 hours.
Get my fixed-fee quote →We're currently implementing ISO 13485 for EverX Pty Ltd, an Australian medical-device manufacturer, building their compliant QMS ahead of accredited certification.
What ISO 13485 certification involves
ISO 13485:2016 is the QMS standard built specifically for medical devices, stricter and more traceability-driven than ISO 9001, because a defect in your product can harm a patient. For Australian manufacturers, importers and sponsors it's the bedrock of ARTG inclusion, TGA conformity assessment and export access into the EU, UK, Canada and the US.
Design controls & design history file
The documented, traceable trail proving your device does what it claims, from design inputs through verification and validation, that the TGA and FDA expect to see.
ISO 14971 risk file
A risk-management process and risk file aligned to ISO 14971:2019, integrated with your clinical evaluation evidence.
Production & sterile manufacturing
Controlled production environments and sterile manufacturing controls, with qualification of the critical-component suppliers you depend on.
Device master record & UDI traceability
A Device Master Record and Unique Device Identifier so every unit can be traced through its whole lifecycle, essential the day a recall or field action is needed.
Complaints & corrective action (CAPA)
Complaint handling, non-conformance and corrective/preventive-action workflows built to survive a regulator inspection.
Post-market surveillance & vigilance
Surveillance and vigilance reporting through TGA IRIS, field safety notices and recall readiness, extended with IEC 62304 and IEC 62366 for software-based devices.
What ISO 13485 does for your business
Sell your device in Australia
ISO 13485 is the baseline QMS the TGA expects before it will assess a conformity application or approve ARTG inclusion, aligned to the Essential Principles.
Open the EU, UK and Canada
The de-facto QMS pillar for EU MDR 2017/745 Notified Bodies, the UKCA transition and MDSAP audits into Canada, from one system.
Get ahead of the FDA's 2026 change
The FDA's Quality Management System Regulation (21 CFR 820) harmonises directly with ISO 13485 from 2026, certify now and your QMS already speaks the FDA's language for 510(k) submissions.
Win hospital and procurement contracts
A growing share of Australian device contracts treat 13485 as a prequalification, unlocking hospital tenders and supply agreements.
Meet your Australian Sponsor obligations
Gives Australian Sponsors the documented evidence they need to support manufacturer and conformity obligations under TGA rules.
One QMS, every major market
A single accredited certificate opens ARTG (AU), CE (EU), UKCA (UK) and FDA pathways, instead of a separate project per region.
Who ISO 13485 is for in Australia
Not sure if ISO 13485 fits your sector? Tell us what you do, we'll tell you straight, no pressure.
Get my fixed-fee quoteWhat does ISO 13485 certification cost?
Your fee depends on one thing: the size of your organisation. Tell us your headcount and we'll send a single fixed fee covering gap analysis, documentation, consultancy and your certification audit, agreed upfront, no hourly billing, no surprises.
Five steps to certified
One dedicated Australian consultant from quote to certificate, we do the heavy lifting.
- 01
Quick quote & scope
Tell us your standard and headcount, your quote arrives within 24 hours, agreed before we start.
- 02
Gap analysis
Your dedicated consultant maps what you already have against the standard, so you only build what's missing.
- 03
System build
We write the policies, procedures and records with you, tailored to how your business actually operates.
- 04
Implementation & internal audit
We embed the system, train your team and run the internal audit to confirm you're ready.
- 05
Certification audit
We prepare and support you through the audit, independent or JAS-ANZ accredited, your choice.
EFQM 5★ Recognised for Excellence
Fewer than 400 organisations worldwide hold it, IMSM is one of them
Think of it as ISO certification for our own business, we hold ourselves to the same standard we hold you to.
It's an independent assessment of our own quality management against the European Foundation for Quality Management framework.
ISO 13485, common questions
How does ISO 13485 certification work, who issues the certificate?＋
We handle the full implementation, building your compliant 13485 QMS, and arrange your certification audit through a JAS-ANZ (or internationally equivalent) accredited body. An accredited certificate is what the TGA, EU MDR and FDA recognise for medical devices.
We're already ISO 9001 certified, can we bridge?＋
Partly, 9001 gives you maybe 40–50% of the structure (document control, management review, CAPA), but 13485 adds design controls, risk management, sterile production, post-market surveillance and regulatory-file requirements 9001 doesn't touch.
How does 13485 interact with TGA conformity assessment?＋
A compliant 13485 QMS is typically the foundation of a TGA conformity-assessment evidence package, and for higher-risk devices (IIa and above) it significantly compresses assessment time and reduces back-and-forth with the TGA.
Do we need ISO 14971 as well?＋
Practically, yes, 13485 references a risk-management process and ISO 14971:2019 is the de-facto expectation of Notified Bodies, the TGA and the FDA, so we build your risk file alongside the 13485 project.
Does 13485 apply to Software as a Medical Device (SaMD)?＋
Yes, SaMD is regulated as a device by the TGA, and we extend 13485 with IEC 62304 (software lifecycle), IEC 62366 (usability) and cybersecurity considerations so it holds up under inspection.
How long will certification take?＋
Most medtech businesses certify in as little as 2 months from kick-off, with a clear fixed timeline agreed upfront. We move as fast as your evidence and device class allow.
What about MDSAP and the FDA?＋
13485 is accepted as the QMS pillar of MDSAP for audits into Canada, and from 2026 the FDA's QMSR harmonises directly with ISO 13485, supporting your 510(k) documentation and reducing duplication at inspection.
Ready to get ISO 13485 certified?
Most clients have their quote within 24 hours. Let's see what certification looks like for your business.