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Medical Devices




                                                                                                                              ISO 13485 and ISO 14971

























                                                                                                                              ISO 13485

       Our ISO 13485 quality management training will help you                                                                Introduction to ISO 13485:2016                          ISO 13485:2016 Clause by Clause

       to understand the QMS requirements for medical devices,                                                                This course has been designed to provide an             This course has been designed to provide an in

       so you can ensure that you maintain compliance.                                                                        insight into the use of ISO 13485:2016 as the basis     depth understanding of ISO 13485:2016 by
                                                                                                                              for a quality management system implemented by          reviewing the requirements of each clause in turn,
       By attending training on ISO 14971 you can understand how                                                              medical device manufacturers.                           allowing you to maintain a compliant QMS.
       to improve your business through risk management efforts
                                                                                                                              Duration 1 day                                          Duration 2 days includes optional online exam
       and understand how ISO 14971 applies to ISO 13485.























       bsigroup.com/en-ZA  I  +27(0)12 004 0279  I    bsi.za@bsigroup.com                                                                                                                                                              21
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