![]() ![]() The Standard is based on the approach of the general Quality Management System Standard, ISO 9001. NSAI can offer registration to ISO 13485:2016, which sets out the requirements for a quality management system (QMS) applicable to designers and manufacturers of medical devices. Presentation - NSAI ISO 13485 & MDR Seminar, May 2016.You can also receive information on NSAI seminars direct by subscribing to the NSAI E-zine. Please follow the NSAI Seminars web page for information on any future events as it becomes available. NSAI held two morning seminars, one in Dublin and one in Galway, on ISO 13485:2016 & the MDR, the presentation given at these events is available below. ISO 13485:2016 Technical Questionnaire (MS Word copies are available from your NSAI auditor) This latest NSAI presentation is now available to view hereĭocuments referenced during this presentation: Hosting a seminar in both Dublin and Galway NSAI Medical Device staff gave presentations on the transition to, and what's new in, ISO 13485:2016 and the major changes and impacts on industry of the MDR. The NSAI Medical Device department has just completed its latest Roadshow on 'ISO 13485:2016 and the MDR - Major Changes and Impacts'. ISO 13485 – quality management systems for medical devices ![]()
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