ISO 13485 — Your Foundation for Global Medical Device Market Access
ISO 13485:2016 is the gold standard quality management system for medical device manufacturers worldwide. RABT Global’s ISO 13485 consulting services cover gap analysis, full QMS implementation, MDSAP alignment, and certification audit preparation — giving you the quality system that opens markets.
Find out exactly what your QMS needs to achieve ISO 13485 certification — at no cost. Our specialists will review your current system and identify the gaps.
ISO 13485:2016 is the international standard specifying requirements for a quality management system (QMS) specific to organisations involved in the design, development, production, installation, and servicing of medical devices and related services.
In plain English: ISO 13485 is the QMS standard that medical device manufacturers worldwide use to demonstrate that their quality systems meet regulatory requirements — and that their devices are consistently safe and effective.
Who needs ISO 13485?
- Manufacturers seeking CE marking under EU MDR (QMS assessment by Notified Body is required for Class IIa+)
- Manufacturers seeking to supply FDA-regulated markets (ISO 13485 aligns with FDA QSR / 21 CFR 820)
- Device suppliers and contract manufacturers requiring supplier qualification
- Any manufacturer pursuing MDSAP (Medical Device Single Audit Programme)
- Manufacturers seeking registration in Canada (Health Canada), Australia (TGA), Japan (PMDA), or Brazil (ANVISA)
ISO 13485:2016 — One Standard, Multiple Markets
| Market / Regulation | How ISO 13485 Aligns |
|---|---|
| EU — EU MDR 2017/745 | ISO 13485 aligns with EU MDR QMS requirements (Annex IX). NB QMS assessment is based on ISO 13485 for Class IIa, IIb, and III device certification. |
| USA — FDA QSR (21 CFR 820) | FDA has harmonised its Quality System Regulation with ISO 13485 through the new QSR (Quality Management System Regulation, 21 CFR Part 820 update). ISO 13485 is increasingly accepted as meeting FDA QSR intent. |
| Canada — Health Canada | ISO 13485 certification (by an MDSAP-approved auditing organisation) is required for most Class II–IV device licences in Canada. |
| Australia — TGA | ISO 13485 is aligned with Australia’s ARTG requirements for medical device quality management. |
| Japan — PMDA | Japan’s MHLW/PMDA quality system requirements are closely aligned with ISO 13485. |
| MDSAP | The Medical Device Single Audit Programme (MDSAP) is the single-audit route to satisfying FDA, Health Canada, TGA, ANVISA, and PMDA QMS requirements — using ISO 13485 as the QMS standard. |
ISO 13485 Consulting — FAQs
A: No. ISO 13485:2016 is a medical device-specific standard with additional requirements beyond ISO 9001 — including device-specific risk management (ISO 14971), post-market surveillance, complaint handling, advisory notice management, and regulatory reporting. ISO 13485 does not require the continual improvement focus of ISO 9001 — instead, it focuses on maintaining the effectiveness of the quality system.
A: ISO 13485 scope can apply to component and sub-assembly manufacturers who are part of the device supply chain. Manufacturers of final devices typically require their critical suppliers to hold ISO 13485 certification or demonstrate equivalent quality system controls. RABT Global advises on whether your specific supply role triggers an ISO 13485 requirement.
A: Yes. RABT Global has extensive experience implementing ISO 13485 QMS for startup and early-stage medical device companies — building quality systems that are right-sized for your current stage but scalable as you grow. We structure the QMS to support CE marking and FDA regulatory activities from day one.
A: ISO 13485 forms the basis of the QMS assessment conducted by your EU Notified Body for CE marking under EU MDR 2017/745. An ISO 13485-certified QMS — with EU MDR-specific process controls — is a prerequisite for most Class IIa, IIb, and III device CE marking programmes. RABT Global aligns ISO 13485 implementation with EU MDR Annex IX requirements simultaneously.
Build the Quality System That Opens Global Markets
Expert ISO 13485 consulting services — from gap analysis to certification and beyond. One QMS standard. Multiple markets. Delivered by RABT Global.