Comparación ISO 9001:2008 vs ISO 9001:2015
Nuestros consultores han trabajado en prepararles un análisis de las diferencias entre las 2 normas.
Para descargarla: entren a http://www.symaconsulting.com/iso-90012015/
Cambios en Francia para la comercialización de dispositivos medicos estériles con uso para bebes, recién nacidos y prematuros. Con aplicación mandatoria en los 6 próximos meses ! Para más información info@symaconsulting.com y: ansm – ETO
Medical Devices Regulation postponed by a year in the EU. “With patient health and safety as a guiding principle, the Commission adopted a proposal on 3 April 2020 to postpone the application date of the Medical Devices Regulation (MDR) for one year. The goal is to have the Parliament and Council adopt the proposal by…
Reference: http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref2011 A standard for quality management systems specific to the medical devices industry is under review and has just moved a step closer to completion. We take it for granted that devices used in hospitals or medical centres are of high quality and up to scratch, but for manufacturers, the risks of getting it…
Hey, Ms. Auditee: Did Mickey Mouse Do Your Root Cause Analysis?: http://www.qualitydigest.com/inside/quality-insider-article/hello-mr-auditee-did-mickey-mouse-do-your-root-cause-analysis.html
Ya se publico la nueva norma ISO 13485:2016 !!! http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=59752 Pregunta por nuestro curso ! info@symaconsulting.com
4 new guidances related to Clinical investigation and evaluation were recently published on the commission website including a template for the PMCF, the guidance on sufficient clinical evidence for legacy devices and a guidance for equivalent devices ! https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en