ISO 13485:2016 Now replaces the previous version of the standard, EN ISO 13485:2012, in the EU Official Journal, with the date of cessation of 31 March 2019. ISO 13485:2016 Introduction We cover various clauses of the medical device standard and how to manage your quality system to achieve compliance with the standard. ISO 13485:2016 Clause by Clause This training provides an in depth review of ISO 13485:2016. We breakdown the clauses to provide an understand the implications behind the quality management requirements for medical device manufacturers. ISO 13485:2016 Transition & Auditor Refresher We identify the key changes in ISO 13485:2016 and refresh your auditing skills to align with the new standard. … Continue reading Medical Device Training