Effective quality management systems are recognized as a key regulatory consideration for allowing medical device manufacturers to market their products around the world. ISO 13485 provides a focus for the quality management system requirements for medical device manufacturers.
BSI Management Systems Training can provide training to help you implement a successful Medical Devices Management System. Select a course below to find out more.
Awareness courses
This one-day introductory course will give students a broad understanding of the ISO 13485 Quality Management Systems requirements.
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Auditor courses
This course is designed for those with knowledge of medical device manufacturing and starts with one full day of review of ISO 13485.
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This course begins with a review of requirements of ISO 13485 and continues to teach the principles of process auditing in accordance with quality management system standards and ISO 19011:2002, "Guidelines for Quality and/or Environmental Management Systems Auditing."
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