ISO 13485 Certification
Quality Management for Medical Devices
Internationally Recognized Certification for Medical Device Quality Systems
ISO 13485:2016 is an internationally recognized Quality Management System (QMS) standard tailored to organizations in the medical device industry. Achieving ISO 13485 certification demonstrates your commitment to quality, safety, and regulatory compliance throughout the entire medical device lifecycle.
Why Choose DEKRA for ISO 13485 Certification?
DEKRA’s audit team consists of experts with extensive experience to accurately assess the compliance of your management system with ISO 13485 standards.
- Trusted Expertise – With over 30 years of experience as a recognized Certification Body, DEKRA provides accurate and reliable ISO 13485 certification services.
- Dedicated Support – We provide a single point of contact for your entire ISO 13485 certification journey.
- Global Reach – DEKRA Medical Services operate directly in 7 countries, offering access to local expertise and key international markets, including the EU, UK, and beyond.
Why ISO 13485 Certification
Having an ISO 13485-certified QMS enhances credibility, expands business opportunities, and meets industry expectations across global supply chains.
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2. Choose DEKRA
3. Planning of Activities
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5. ISO 1385 Certification
Get ISO 13485 Certified with DEKRA
Join the growing number of ISO 13485 certified companies worldwide and gain a competitive edge in the medical device industry. Contact us today to start your certification process!