ISO 13485 certification - Quality management for medical devices
Achieve global market access and regulatory compliance with confidence through DNV’s ISO 13485 certification services for medical device quality management systems.
ISO 13485 certification - Quality management for medical devices
Achieve global regulatory compliance with confidence. Let DNV support you in implementing and certifying a medical device QMS aligned to ISO 13485. With deep regulatory expertise and a strong international presence, we support organizations through every step of ISO 13485 certification.
We offer integrated audit solutions that combine ISO 13485 with MDSAP and EU requirements such as MDR and IVDR, reducing duplication, saving time, and minimizing disruption to your operations.
What is ISO 13485 certification?
ISO 13485:2016 is the internationally recognized standard for quality management systems (QMS) specific to medical devices, from design, production, and installation to servicing and sales.
Certification demonstrates that your organization consistently meets both regulatory requirements and customer expectations
Who needs ISO 13485 certification?
ISO 13485 certification is intended for manufacturers, including legal manufacturers, as well as companies providing services or activities to medical device manufacturers, including:
- Design and development activities, including software.
- Manufacturing and distribution.
- Installation and servicing.
- Suppliers, contract manufacturers, and other service providers involved in the medical device supply chain.
DNV’s ISO 13485 certification services
We support your certification journey with:
- QMS assessment & audit-readiness: Aligned with ISO 13485 and related regulations like MDR and FDA QSR.
- Full QMS certification audits: Comprehensive evaluation of processes and documentation.
- Regulatory liaison: Audit completion and certification accepted by global authorities.
- Surveillance audits: Annual evaluations to ensure QMS remains compliant.
- Training: Training in the regulatory requirements allowing you to build and improve internal QMS capabilities.
Why choose DNV?
- Global depth, local presence: International audit standards with regional delivery.
- Integrated digital solutions: Leverage DNV support, webinars, and tools to simplify compliance.
- Proven medical device expertise: Deep experience in regulated environments and risk management best practices.
- Holistic process alignment: Audits follow ISO’s process-based approach with emphasis on risk and lifecycle management.
Access tools and resources for ISO 13485 certification
Explore practical guides, templates, and downloads to support your medical device quality management and certification journey.
Medical Device Certification
Ensure compliance, safety, and reliability across your medical device lifecycle with DNV’s globally recognized certification services.
ISO 13485 Quality Management Guide
Download our guide to discover how ISO 13485 supports regulatory compliance, product quality, and operational excellence in medical device manufacturing.
Medical Devices Certification Requirements
Review the key ISO 13485 certification steps, prerequisites, and documentation needed to demonstrate compliance with international standards.
Declaration of Interest
Start your certification journey. Download and complete the Declaration of Interest to begin working with DNV’s medical device experts.
Training and Competence Development
Build internal expertise through practical training programs that strengthen your understanding of ISO 13485 and regulatory requirements.
Your added value
Learn how DNV’s digital tools and customer support deliver transparency, efficiency, and trust throughout your certification process.
