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ISO 13485 Quality Management for Medical Devices Training Courses

Gain a thorough understanding of ISO 13485 with your preferred learning method and achieve certifications.

ISO 13485 Quality Management for Medical Devices Training Courses

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Enroll on our Learning Marketplace: Public training See all ISO 13485 courses

Private training

Become adept in the QMS for Medical Devices (ISO 13485)

Our training can help your organization learn, implement, and maintain ISO 13485 certification. Whether in-person or virtual, our live sessions use accelerated learning techniques, securing your thorough comprehension through interactive workshops and lectures. Discover our on-demand e-learnings and free webinars for flexible learning options.

If you're looking to simply learn the quality management system requirements or become a certified internal or lead auditor, training with our experts will provide what you need. Our medical devices training appeals to all learning styles, offers an enhanced learning experience, and enables various certifications.

Support your personal certification or your organization's

Gain the knowledge to effectively implement and audit ISO 13485 and create a competitive edge that is internationally recognized. ISO 13485 represents the medical device industry's Quality Management System standard. It specifies requirements for an organization to design and implement a QMS to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Popular ISO 13485 QMS for Medical Devices training courses

Our most popular courses are listed below with brief descriptions and links to our BSI Learning Marketplace for more details and to enroll.

Understand the concepts of ISO 13485:2016 standard and how the requirements impact daily operations of organizations in the medical device industry. An experienced instructor will thoroughly explain the clauses and principles, covering the audit requirements for the standard.

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Gain extensive knowledge of the ISO 13485 definitions, concepts, guidelines, and requirements. This course provides in-depth coverage of an auditor’s roles and responsibilities, the principles, practices and types of audits in accordance with Auditing Management System Guidelines (ISO 19011:2018). Get the tools you need to conduct all phases of an internal audit, including preparing and presenting effective audit reports.

This course includes ISO 13485:2016 Requirements training.

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Acquire the expertise and proficiency needed to lead an audit of ISO 13485:2016 accordance with the latest Guidelines on Auditing Management Systems (ISO 19011:2018). Experienced instructors explain the clauses in detail and guide students through the entire audit process, from managing an audit program to reporting on audit results.

This course encompasses training from both the ISO 13485:2016 Requirements and Internal Auditor courses.

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Get an understanding of ISO 13485:2016 and its relevance for medical devices manufacturers. This course explores ISO 13485:2016 requirements by discussing key principles and its interaction with the ISO 9001:2015 Quality Management System and with European regulations (MDR and IVDR).

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Explore the requirements of the ISO 13485:2016 Quality Management System Standard for medical devices and the key principles.

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Become aware of what ISO 13485 is, why it's important, and how your organization can use it to help maintain patient safety.

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