Ya está la nueva ISO13485:2016 !!!
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
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
GMED official publication on linkedin: GMED (CE 0459) has been designated as a Notified Body under the Regulation (EU) 2017/745 by the French National Agency for Medicines and Health Products Safety (ANSM). Equipped with this designation since July 8 2020, GMED has mobilized its teams to offer manufacturers with certification services according to the Regulation…
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
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
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
La ISO 9001, en su próxima versión del 2015, nos exigirá una gestión de riesgos. Una de las metodologías a aplicar puede ser ISO 31000. Se trata de una norma que establece los principios para diseñar, implementar y mantener una gestión de riesgos sistemática y transparente de cualquier forma de riesgo y en cualquier contexto….
When one or more characteristics of a product fail to meet specified requirements, it is referred to as a nonconforming product. When a product deviates from specified product requirements, it fails to conform. Nonconforming products must be identified and controlled to prevent unintended use or delivery. Nonconforming product is defined as product that does not…