Creativity
Minds are like parachutes. They only function when they are open.
~ James Dewar
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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,…
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…
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
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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!
Nice words…
BySylvieGood Decision Good decisions come from wisdom. Wisdom comes from experience. Experience comes from bad decisions. ~ Anonymous