Watch Your Thoughts
Watch your thoughts; they become words.
Watch your words; they become actions.
Watch your actions; they become habits.
Watch your habits; they become character.
Watch your character; it becomes your destiny.
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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…
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,…
Nice words…
BySylvieGood Decision Good decisions come from wisdom. Wisdom comes from experience. Experience comes from bad decisions. ~ Anonymous
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.
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…