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Ana Burgos from
#MDCG describes the process for the joint assessment & designation of#Notifiedbodies.#RegSummitSE#swemedtech#mdr#IVDRpic.twitter.com/ilC0tbCdbr
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Discussing
#medicaldevices and the new#eudirective with EU colleagues.#medicine and#devices getting closer. Will require increased focus from#competent#authorities and strong collaboration- and very strong#notifiedbodies.#dkmedicin#lifesciencepic.twitter.com/nu1t2zdFny
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Thank you
@medtecheurope and@LMSTdk for joining our board meeting to discuss the current situation regarding#NotifiedBodies#sundpolpic.twitter.com/7ssjXh7RDd
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EU
#NotifiedBodies What's happening? Is it a 'domino effect'? https://bit.ly/2Jn8A9Q pic.twitter.com/dGtppowXqD
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Looking forward to the
#ESN2019 next week, to talk about@covrproject and the concepts of#safetyskills and#protocols and how they relate to#standardization,#testing and#notifiedbodies in the#EU.https://twitter.com/EUROSHNET/status/1115910325046476803 … -
#EA HHC meeting: Extensive discussions on sector schemes,#NotifiedBodies and consultancy, scope of#Accreditation for regulatory purposespic.twitter.com/VYM0zMgRSl
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UK moves to mitigate impact of notified body withdrawals https://www.medtechdive.com/news/uk-moves-to-mitigate-impact-of-notified-body-withdrawals/571379/ …
#MDR#notifiedbodies#eudamed -
With 45% of devices accessing the EU via UK
#NotifiedBodies, what would be the impact of a so-called “hard#Brexit?” Read here: http://bit.ly/2OgAu7r pic.twitter.com/nfkwaq4pT9
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What are some of the regulatory challenges that complex combined products pose to conformity assessment by
#NotifiedBodies? Some great insights by@dr_akra from@TUVSUD#MPP2019pic.twitter.com/zAp1xPE6x2
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WHY aren't medical devices SAFE? A series of PRIVATELY owned companies called
#notifiedbodies, paid by manufacturers, issue#CE marks.#PIP chose@TUVRheinlandNA to certify#PIP keeping PIP on global market for >10yrs after#FDA BANNED them!@BBCPanoramahttps://bbc.in/2r3W7hq -
What’s next for
#NotifiedBodies? Read our latest blog: http://bit.ly/2N7x3Uo#EURegulationspic.twitter.com/Ywrp6cAIqx
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Looks like three more
#notifiedbodies are the final stage of certification for#EUMDR, which would bring the total to 12. Watch the NANDO database for updates. http://bit.ly/2t56qq7 pic.twitter.com/jqK9glNahy
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OMG!
@MedtechAmanda#IVD Regulation increases workload of EU#notifiedbodies by 780%, MedTech Europe’s Pirovano tells#RMD2018 -
>90% companies currently operating under
#ISO13485 in India can't do a decent#InternalAudit. So called#TrainedInternalAuditors by#Notifiedbodies can't even pen down audit notes and hardly make a loop while auditing.#Eyewash -
Surprise! More about
#unannouncedaudits by#notifiedbodies for#medicaldevices from the@rapsorg#2014RAPShttp://wp.me/p1btIG-zS -
There are increased
#requirements for#notifiedbodies. To check: (1) Notified Body accredited according to#MDR? (2) Does the scope of its designation cover all products in its own portfolio? (3) Cooperation - Timeline#Bottleneck#EUMDR@SchuhMiriam#Albis#Healthcare Lounge -
Learn how to prepare for unannounced visits from
#notifiedbodies by attending this webinar at 1pm: http://ow.ly/FGoMH@lifescienceti -
EC Update - MDCG Q&A on requirements relating to Notified Bodies - https://lnkd.in/danTaaq
#eudamed#mdr#medicaldevices#regulatory#notifiedbodies https://lnkd.in/eKfUHfA -
CJEU AdvocateGeneral made it clear:
#NotifiedBodies CANT HIDE: WHERE THERE IS CULPABLE NEGLIGENCE, THERE IS LIABILITY!#TÜVRheinland licensed#PIPimplants with#CEmark for >10yrs after PIP were BANNED in USA!#GuiltyAScharged#PIPcrimes http://bit.ly/2IMg98j@AFP@laurentgaudon
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