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GMED designated under Regulation (EU) 2017/745 on medical devices
BySylvieGMED 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…
FDIS ISO 13485:2016
BySylvieYa estamos estudiando el FDIS de la ISO 13485:2016. El borrador se encuentra http://www.iso.org/iso/fr/home/store/catalogue_tc/catalogue_detail.htm?csnumber=59752 La publicación de la versión final está todavía programada en Marzo 2016. Quedense al pendiente de nuestro gap analysis ! Más información info@symaconsulting.com
Medical Devices Class Ir – Transitional Provisions to MDR
BySylvieIt is not easy to follow how and when to apply the new future MDR, a big pressure has been set on the class I reusable medical devices manufacturer to be ready to transition, yes but by when? Well back in July, the rules have changed again but are offering a longer transition period –…
Nice words…
BySylvieGood Decision Good decisions come from wisdom. Wisdom comes from experience. Experience comes from bad decisions. ~ Anonymous
Super Oferta Curso ISO14001
BySylvieNos quedan algunos lugares para nuestra capacitación del 3 de Abril “Introducción en la Norma ISO 14001, Sistemas de Gestión Ambiental”. Para este curso, tenemos actualmente un 30% de descuento en el curso de un día en Polanco, DF. Interesados comunicarse con Adriana Gutiérrez: info@symaconsulting.com o teléfono: 15556623.
ISO 9001:2015 vs. ISO 9001:2008
BySylvieLa norma ISO 9001 está evolucionando ! En 2015 se publicará la nueva versión de la norma, ya están preparados al cambio ? Registrate a nuestro curso en Polanco DF: info@symaconsulting.com

