ISO 13485 | Quality Management Systems for Medical Devices

What Is ISO 13485?

ISO 13485:2016 is the internationally recognized standard for Quality Management Systems (QMS) in the medical device industry. It emphasizes risk-based decision-making, strengthened regulatory alignment, and robust process controls to ensure consistent quality and safety.

Developed to support regulatory programs like the Medical Device Single Audit Program (MDSAP), this standard is entrusted by global regulatory bodies to set the foundation for product integrity and compliance.

Key Features of ISO 13485:2016

Risk-Based Thinking & Process Control

The standard enhances traditional QMS by embedding risk-based decision-making throughout product design, production, and post-market processes.

Supply Chain & Software Validation Requirements

ISO 13485:2016 places specific emphasis on validating software-related processes and reinforcing supply chain integrity

Regulatory Harmonization

It aligns closely with global regulatory frameworks—including FDA QSR (21 CFR 820), EU directives (MDD/MDR), and more—making it a cornerstone for international market access.

 

Why Choose Intertek for ISO 13485 Certification?

Third-Party Assurance by Experts

Intertek delivers impartial third-party auditing and certification, ensuring your system not only meets the ISO standard, but also strengthens credibility with regulators and stakeholders.

Integrated with Global Audit Programs

Through MDSAP, Intertek enables a single audit to satisfy regulatory requirements across multiple jurisdictions, streamlining compliance and minimizing audit fatigue.

Expanding Global Recognition

Effective April 1, 2025, SAHPRA (South African Health Products Regulatory Agency) now requires ISO 13485 certification from a recognized body. Intertek is a trusted SAHPRA-recognized issuer, enabling smoother market access to South Africa

UKCA Conformity Assurance

Intertek’s Medical Notified Body is also designated to issue UKCA conformity assessments under the UK Medical Devices Regulation—supporting access to the Great Britain market post-Brexit through UKAS-accredited ISO 13485 certification.

Support & Industry Resources

Training & Professional Development

Access Intertek Academy’s training programs, including Lead Auditor and Internal Auditor courses, tailored to ISO 13485 requirements and audit execution.

Ready to Elevate Your Medical Device QMS?

Get Certified with Confidence

Partner with Intertek to achieve effective ISO 13485:2016 certification—backed by global recognition, integrated audit paths like MDSAP, and emerging regulator approvals.

Contact Intertek today to begin your ISO 27001 certification journey and demonstrate your commitment to protecting information and reducing risk.

👉Contact: ISO 13485 | Quality Management Systems for Medical Devices

More Information

SAI Global Standards is an Intertek company - Access and purchase ISO 13485 standard in a format that suits your needs.

 

Complaints Handling Process

Information on the Intertek Business Assurance Complaint Handling Process can be found on the GOP-216-INFO document.

Related Industry Solutions

• MDSAP - Medical Device Single Audit Program
• The EU Medical Devices Regulation (MDR 2017/745)
• ISO 22716 – Good Manufacturing Practices for Cosmetics
• Indian Certification of Medical Devices Scheme (ICMED)
• Medical Devices Directive 93/42/EEC

• Seven Steps to Certification
• 9 Ways to Prepare for an Initial Certification Audit
• Transfer Your Management Systems Certification