ISO 13485:2016


ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

Whether your organization is seeking certification from scratch or looking to maintain your existing certification to ISO 13485, Plexus International has the solution to accommodate your training and consultation needs.

ISO 13485:2016 Medical Devices

- *$1233

ISO 13485 > Instructor-led Learning
Designed for new and current internal auditors, this course will provide you with the necessary knowledge of ISO 13485 and the skills to evaluate the effectiveness of the quality management system at your organization. You will be guided through the internal audit process, from planning an audit to reporting on audit results and following up on corrective actions.


- *$1233

ISO 13485 > Instructor-led Learning
Learn the concepts of ISO 13485 and how the standard can become a valuable part of your business management system. This course is designed to provide you with insight into the use of ISO 13485 as the basis for a quality management system implemented by medical device manufacturers.


* prices listed are for base options and may change based on purchase selections.
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