ISO 13485 Certification for Medical Devices

Validating Your Quality Management System

Certifications play a crucial role, especially when it comes to medical devices. They not only help build trust but have become a mandatory requirement to do business in today's competitive global marketplace. As an accredited registrar, TÜV Rheinland provides medical device manufacturers ISO 13485 quality management system certification. Compliance with ISO 13485 not only improves a company's management techniques, but also reassures consumers the medical product has been tested and certified for safety and performance. Our experts assist companies improve their processes, increase work efficiency, uncover opportunities for improvement, and gain international recognition.

ISO 13485 certification process begins with a thorough documentation review, followed by an on-site visit to review and assess the day to day operations. Upon successful completion of the audit, your organization will receive ISO 13485 certification.

Benefits at a Glance

With ISO 13485 certification from TÜV Rheinland, you can:

  • Ensure compliance with the requirements of the standard and more
  • Streamline your processes, increasing efficiency resulting in significant time and cost savings
  • Gain a competitive edge with our independent, globally recognized third party certification
  • Benefit from using a single source for all your testing and certification needs
  • Take advantage of our wealth of international experience, expertise and global presence in the medical devices market

Our Services for EN ISO 13485

On your way to increased safety and quality, TÜV Rheinland experts offer a comprehensive range of certification services.

  • EN ISO 13485 certification for your quality management system
  • EN ISO 13485 certification for Health Canada (CMDCAS)
  • EN ISO 13485 certification for the Japanese Ministry of Health (PAL)
  • EN ISO 13485 certification for the Taiwanese Department of Health (TCP)
  • EN ISO 13485 certification for processing of medical devices
  • EN ISO 13485 certification as a basis for FDA compliance

Four Steps to Your Certificate

1. Optional Preliminary Audit
We provide consultation and preliminary assessment during which we inspect your site and review your quality management documentation

2. Initial Certification Audit: Phase 1
We audit your site to determine your eligibility for certification and analyze all the required documentation for compliance with EN ISO 13485.

3. Initial Certification Audit: Phase 2
We conduct an on-site review, assessing how your quality management system is applied in practice and evaluate how effective it is.

4. Certificate
Upon successful completion of the audit, we issue a certificate confirming compliance with standards and the integrity of your quality management system.

TÜV Rheinland: an Internationally Recognized Testing Body

EN ISO 13485 certification gives you advantages worldwide. In addition to doing business in Europe, this certification is a prerequisite for marketing your products in other international markets. We can evaluate compliance with the standards of regulators, such as Health Canada, the Japanese Ministry of Health (MHLW), and the Taiwanese Department of Health (DOH). By combining certifications, you can save time and money and facilitate product rollouts.