ISO 13485 — Medical Devices Quality Management
ISO 13485 sets requirements for a quality management system specific to organisations involved in the design, production, installation and servicing of medical devices.
Why it matters
Regulators worldwide reference ISO 13485 as the benchmark quality system for medical device manufacturers, aligning with regulatory requirements such as the EU MDR and FDA QSR.
Certification demonstrates risk-based process control, traceability and regulatory compliance across the device lifecycle.
WHY PURSUE THIS
Benefits of ISO 13485 certification
Regulatory alignment
Supports EU MDR, FDA QSR and other global medical device regulatory frameworks.
Patient safety
Risk-based design and production controls reduce harm to end users.
Full traceability
Device history records support rapid, accurate recall action if ever needed.
Market access
A near-universal requirement for medical device market entry.
STAKEHOLDER TRUST
Supporting the Sustainable Development Goals (SDGs)
SDG 3
Good Health and Well-being
SDG 9
Industry, Innovation and Infrastructure
SDG 12
Responsible Consumption and Production
“In medical devices, quality management is not a formality, it is the difference between safe and unsafe care.”
Priya Nair, Lead Medical Devices Assessor, RBA Registrars
Organisations that benefit from certification
Non-Active Medical Devices
Active Medical Devices (Non-Implantable)
Active Implantable Medical Devices
In Vitro Diagnostic Medical Devices (IVD)
Sterilization for Medical Devices
Devices Incorporating / Utilizing Specific Substances or Technologies
Manufacturing of Parts or Services
What we audit
What we assess for Medical Devices QMS
Our assessors evaluate objective evidence against each focus area below and record findings in a formal audit report.
01
Design & Development Controls
Design inputs, verification, validation and design history file requirements.
02
Risk Management (ISO 14971)
Integration of product risk management throughout the device lifecycle.
03
Production & Process Controls
Process validation, traceability and device history record requirements.
04
Regulatory & Post-Market Surveillance
Complaint handling, vigilance reporting and post-market monitoring.
Related Standards & Services
Explore other certification schemes and services offered by RBA Registrars.
Ready to begin your ISO 13485 certification journey?
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