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Nice words…
BySylvieGood Decision Good decisions come from wisdom. Wisdom comes from experience. Experience comes from bad decisions. ~ Anonymous
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 –…
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…
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
Medical Devices Clearances maybe waived for hundreds of devices in 2021 through an international tender in Mexico!
BySylvieThis is the first time the Mexican Government opens a window for international manufacturers, even if they do not have sanitary registration approvals in Mexico. By Veraque; As published by the UNOPS (United Nations Office for Project Services) the last 25 of August 2020, the Mexican Public Healthcare system signed an agreement to promote an international tender…
Creativity
BySylvieMinds are like parachutes. They only function when they are open. ~ James Dewar

