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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…
Medical Devices – Harmonized Standards MDD – New Listing
BySylvieIn March this year, a new list of harmonized standard was published, see the new list in this link: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices/ You need to download the files now in order to see the list.
E-learning platform
BySylvieWe are proud to announce the launch of our new e-learning platform: First training published “MDSAP en español”. Recording as we speak: ISO 9001:2015 en español, MDR in english. Contact us for more information!
Eficacia Efectividad Eficiencia
BySylvieEficacia vs/o Efectividad vs Eficiencia Eficacia: Capacidad de lograr el efecto que se desea o se espera tras la realización de una acción. Se cumple con un determinado objetivo planeado con anterioridad. Efectividad: Es prácticamente lo mismo que eficacia, la diferencia radica en que se refiere a una medida por medio de la cual pueden…
Rework vs Repair
BySylvieRepair vs Rework A general rule applied by many in automotive is: Rework puts the part into the same condition that a first run good part would be. Repair puts the part into functional suitable condition, but it is apparent that some additional work was done. Rework Definition : Correcting of defective, failed, or non-conforming item,…

