Descripción
Main Topics
ISO 13485:2016 focuses on ensuring compliance with applicable regulatory and standards requirements, as well as improving the quality and safety of medical devices. Its implementation has a significant impact by improving product reliability, strengthening risk management, increasing operational efficiency and fostering customer and stakeholder confidence.
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- Introduction to ISO 13485:2016 sets out the requirements for the quality management system for medical devices. This standard applies to organizations involved in the design, development, production, installation and servicing of medical devices.
- Medical device quality management system principles associated with 13485:2016 include a focus on risk, regulatory compliance, customer satisfaction, continual improvement, and senior management accountability.
- Workshop on the principles of the quality management system for medical devices related to 13485:2016 where the practical application in the context of medical devices is explored. This workshop provides participants with the opportunity to learn how to implement and maintain an effective quality management system in compliance with the requirements of the standard.
- Improvement tools and methodologies are techniques used to identify, analyze and address problems or areas for improvement in a quality management system.
- The requirements of ISO 13485:2016 establish guidelines for the design, development, production and distribution of medical devices.
- Workshop on the application of the requirements of 13485:2016: participants are guided through the specific requirements of the standard and are provided with guidance on their implementation.
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