ISO 13485:2016
Fundamentals of ISO 13485:2016 – Quality management systems for medical devices
This is a basic course that is ideal for anyone interested in learning the purpose of 13485:2016, as well as how to apply its principles and requirements to establish, implement, and operate a Medical Device Quality Management System based on 13485:2016.
This course can be delivered online or on-site, and is typically a precursor module to the Auditor, Lead Auditor, Consultant and/or Coach courses for 13485:2016.
Este curso se puede impartir en línea o en el sitio, y suele ser un módulo precursor de los cursos Auditor, Auditor Líder, Consultor y / o Coach para 13485:2016.
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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.
- 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.
“Quality is not an act, it is a habit”
Aristotle
Learning objectives and teaching methodology
Goals
- Understand the medical device quality management principles underlying 13485:2016
- Know the requirements and intent of 13485:2016
- Learn how to apply the requirements of 13485:2016
- Learn to identify risks and opportunities related to the quality of medical devices
- Gain the tools you need to achieve your organization’s medical device quality goals
Methodology
Our methodology is practical and based on the analysis of real cases that allow the participant to obtain an appropriate balance of theory and practice, facilitating learning and performance.
This course includes support materials and interactive workshops that help students achieve the learning objectives.
This course is 8 hours long and can be taken online or on-site.
Requirements
- Complete theoretical lectures online or on-site
- Complete the two application workshops
Cursos de fundamentos
Contactos
Orlando, FL, USA
618 E. South Street, Suite 500
Escríbenos
info@qsiglobalventures.com