Quality Management Systems Software Validation for Medical Devices Training Course

MDIA Please see the ISO 13485:2016 Medical Devices Internal Auditor Training Course Synopsis for a more comprehensive overview of this course and to review any pre-course requirements that might apply. This course has been prepared by the medical device specialists of SGS and the content approved by SGS United Kingdom Ltd. SGS United Kingdom Limited is approved as Notified Body 0120, a CMDCAS Recognised Registrar, UKAS accredited certification body 005, under the FDA Approved Persons Program and is recognised by many other regulatory authorities including those in Australia and Taiwan. Other medical device approvals in the SGS group include SGS Japan Inc as a JPAL Registered Certification Body and SGS Hong Kong Ltd recognised by the Hong Kong Medical Device Control Office.

MD-CEThe aim of this course is to provide learners with knowledge and interpretive skills necessary to understand and implement the requirements of the new Medical Devices Regulations 2017/745 and Med Dev 2.7.1 Rev 4, Clinical Evaluation in relation to expectations for Clinical Evaluations.Furthermore, learners will have a broader understanding of the changing landscape of regulations related to risk management with an objective of increasing patient safety.