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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.

Why ISO 13485 Certification

    ISO 13485 certification demonstrates that an organization has successfully met the requirements of the standard. In addition to facilitating supplier validation, this certification is increasingly a prerequisite for market authorization in various countries and also complements CE and UKCA marking processes.
    Competitive Advantage
    Having an ISO 13485-certified QMS enhances credibility, expands business opportunities, and meets industry expectations across global supply chains.
    ISO 13485 Certification Process
    1. Request a Quotation
    2. Choose DEKRA
    3. Planning of Activities
    4. Activities
    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!