February 12 – 13, 2024
This virtual instructor-led two-day course covers the requirements of ISO 13485:2016, including the intent, meaning, and interrelationship of the ISO 13485:2016 clauses. This course will also introduce learners to ISO 13485:2016 Medical Devices – A Practical Guide. This guide was developed by ISO TC 210 (the developers of ISO 13485:2016) to assist medical device manufacturers in the practical application of the requirements of ISO 13485:2016 within a quality management system. Learners will demonstrate comprehension through individual and group activities throughout the course as well as a final course challenge.
This course pairs well as a prerequisite to Design Controls for Medical Devices and IVDs (2 day).
Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.
By the end of this training you should be able to: