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Overview
What is ISO 13485:2016?
ISO 13485:2016 is the international standard for quality management systems for medical devices. It specifies requirements for organizations involved in one or more stages of a device's life cycle, from design and production to storage, distribution, installation and servicing, with an emphasis on regulatory requirements, risk management and documented controls.
Who it is for in Saudi Arabia
ISO 13485 is relevant to medical device manufacturers, component and material suppliers, contract manufacturers, sterilization and packaging service providers, and importers and distributors of medical devices.
Accreditation status
TUV United Arabia's SAAC accreditation for ISO 13485 certification is in progress. Please ask our team about the current status when you plan your certification. Our current accreditation scope is shown on our accreditation page.
How certification works
After your application and quotation, the Stage 1 audit reviews your quality management system documentation, including the procedures required by the standard and applicable regulatory requirements, and your readiness. The Stage 2 audit evaluates implementation, including design controls, production and process controls, traceability and complaint handling, as applicable to your scope. The certificate is valid for three years with annual surveillance audits. See our certification process.
Preparing for your audit
As a certification body we do not provide consultancy. ISO 13485 builds on the process approach of ISO 9001, so organizations already certified to ISO 9001 often find the structure familiar.
Reference: ISO 13485:2016 on iso.org.
Why Get Certified
Key Benefits of ISO 13485:2016
Regulatory Market Access
ISO 13485 certification is a prerequisite for CE marking in Europe and is recognized by regulators in the USA (FDA), Canada (Health Canada), and Saudi SFDA.
Patient Safety
Rigorous quality controls throughout the product lifecycle reduce device failures and ensure consistent safety and performance for end users.
Design Control Excellence
Structured design and development controls ensure medical devices meet intended purposes, clinical requirements, and regulatory specifications.
Traceability & Recall Readiness
Comprehensive traceability systems enable rapid, targeted product recalls if needed, minimizing patient harm and regulatory exposure.
Supply Chain Confidence
Certification signals robust supplier controls to hospital procurement teams, distributors, and regulatory bodies in key markets.
Business Growth
Opens tender opportunities with government health ministries, hospital networks, and international distributors who mandate ISO 13485 certification.
Who Should Certify
Is ISO 13485:2016 Right for Your Organization?
ISO 13485:2016 is suitable for any organization regardless of size, industry or sector.
Ready to Get ISO 13485:2016 Certified?
Our expert auditors will guide you through every step of the certification process.
How It Works
Your Path to ISO 13485:2016 Certification
Application
Submit your online application with company details and certification scope.
Gap Analysis
Our auditor conducts a preliminary review to identify any gaps in your system.
Stage 1 & 2 Audit
A two-stage audit process evaluates your documentation and implementation.
Certification
Receive your EGAC-accredited ISO certificate valid for 3 years.
FAQ
Common Questions About ISO 13485:2016
Related Standards
Other standards in the Healthcare category
Ready to Get ISO 13485:2016 Certified?
Join 500+ organizations across the region that trust TUV United for their ISO certification needs.