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ISO 13485 Medical Devices Quality Management Systems (MDQMS)

ISO 13485 is an internationally recognized standard that outlines the specific requirements for a comprehensive quality management system (QMS) for the entire life cycle of medical devices. This includes the design, development, production, installation, and servicing of medical devices, as well as organizations solely focused on producing or manufacturing educational products, such as textbooks or software.

  • ISO 13485 focuses on ensuring the safety and effectiveness of medical devices through strict protocols and risk management practices, thereby reducing the risk of patient harm.
  • The standard helps organizations meet various regulatory requirements for medical devices in different countries. This simplifies market access and avoids potential compliance issues.
  • Higher quality and a more consistent product for healthcare providers and patients.
  • Enhancing brand reputation and build trust with healthcare professionals and regulatory bodies.
  • Efficient processes, reducing errors, and improving cost control throughout the medical device lifecycle.

Journey to Certification

Whether you’re looking to implement ISO 13485 for the first time, transferring your certificate, or having years of experience with quality management systems in the medical device industry, TWR supports clients through every step of their journey. When your application is complete, we appoint a client manager to guide you through the process.

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