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Transitioning from the Medical Device Directives (MDD) to the Medical Device Regulation (MDR)

  Рет қаралды 38,440

MasterControl

MasterControl

Күн бұрын

Пікірлер: 16
@sathyabarathy5837
@sathyabarathy5837 5 жыл бұрын
I have never been so patient ever in my life to listen to an hour long presentation online. Hats off to you Linda for making this presentation; so interesting and extremely useful! Thanks a million !
@derajil3851
@derajil3851 4 жыл бұрын
agree!!!
@tinkeringeekkissimmeefl4495
@tinkeringeekkissimmeefl4495 3 жыл бұрын
Thank you Linda for a very detailed explanation of the MDR. Excellent job! The effective of the MDR has been extended to May 2021 and the implementation of Eudamed is behind schedule, would you please consider making another video update on the status of the MDR? That would be super helpful. Thanks.
@everestmalta2505
@everestmalta2505 6 жыл бұрын
A well done for this detailed presentation that helps law/compliance students as well as companies understand the changes that the European Union is willing to introduce. Ms Chatwin, who is a very experienced person in the field, manages to cover the entire MDR with remarkable accuracy in one hour.
@fay275
@fay275 3 жыл бұрын
Well done Linda.. Very insightful.. Appreciate. Faith from South Africa
@sailaja2k
@sailaja2k 3 жыл бұрын
Very nice presentation and you made it interesting for the listeners, it was very helpful presentation for me, thank you
@MasterControlVideo
@MasterControlVideo 3 жыл бұрын
Glad it was helpful!
@kusumshaikh1154
@kusumshaikh1154 3 жыл бұрын
Well done..you have explained thing in very detail n in clearway
@imcintertech2066
@imcintertech2066 4 жыл бұрын
Nice video! Thanks for sharing!
@MasterControlVideo
@MasterControlVideo 4 жыл бұрын
Thanks for watching!
@Heisenberg2097
@Heisenberg2097 4 жыл бұрын
If clinical routine were only half as serious about things as she is about some paper making a lot of statements and demands... I would feel so much saver. But I do like the increased pressure on the notified bodies. However. More documentation requirements do not yield more safety... Precision and focus will.
@dmitrybolotov1608
@dmitrybolotov1608 4 жыл бұрын
Great guide, tnx a lot it was very useful, where I can see full text of MDR?
@Nereus00
@Nereus00 5 жыл бұрын
can you do one video also about GMP?
@AnantShah-cu6bl
@AnantShah-cu6bl Жыл бұрын
i have a question on Classification question for you. Can you help me answer this question to me? We have 45 different Hand dental instruments in our portfolio. We have combined them in 4-Catagories for our Technical file for MDR. is this a good approach? ITEM# Device Classification name Name Instrument Class- I, IR , IS,Im, Class Iia, Iib and Class III Technical Document Category 1 Tray, Surgical, Instrument I Do Not Do 2 Curette, Periodontic Ir Hygiene Done 3 Instrument, Hand, Calculus Removal Ir Hygiene Done 4 Probe, Periodontic Im Probe 5 Carrier, Amalgam, Operative I Restorative 6 Carver, Dental Amalgam, Operative I Restorative 7 Carver, Wax, Dental I Restorative 8 Condenser, Amalgam and Foil, Operative Ir Restorative 9 Curette, Endodontic Ir Restorative 10 Excavator, Dental, Operative Ir Restorative 11 Explorer, Operative Ir Restorative 12 Forcep, Dressing, Dental Ir Restorative 13 Forceps, Articulator Paper I Restorative 14 Handle, Instrument, Dental I Restorative 15 Instrument, Cutting, Operative Ir Restorative 16 Instrument, Ligature Tucking, Orthodontic Ir Restorative 17 Instrument,Filling,Plastic, Dental I Restorative 18 Instruments, Dental Hand I Restorative 19 Mirror, Mouth I Restorative 20 Plier, Orthodontic I Restorative 21 Plugger, Root Canal, Endodontic Ir Restorative 22 Pusher, Band, Orthodontic ir Restorative 23 Remover, Crown Ir Restorative 24 Scissors, Collar and Crown Ir Restorative 25 Setter, Band, Orthodontic I Restorative 26 Spatula, Surgical, General & Plastic Surgery I Restorative 27 Spreader, Pulp Canal Filling material, Endodontic 1r Restorative 28 Burnisher, Operative I Surgical 29 Chisel, Bone, Surgical Ir Surgical 30 Curette, Surgical, Dental Ir Surgical 31 Elevator, Surgical, Dental Ir Surgical 32 File, Bone, Surgical Ir Surgical 33 File, Periodontic Ir Surgical 34 Forcep, Rongeur, Surgical Ir Surgical 35 Forcep, Tooth Extractor, Surgical Ir Surgical 36 Forceps Ir Surgical 37 Handle, Scalpel Ir Surgical 38 Hemostat, Surgical Ir Surgical 39 HOE, Periodontic Ir Surgical 40 Holder, Needle, Gastroenterological I Surgical 41 Instrument, Manual, Surgical, Generate Use Ir Surgical 42 Knife, Periodontic Ir Surgical 43 Retractor, All Types Ir Surgical 44 Scissors, Surgical Tissue, Dental Ir Surgical 45 Unit, Suction Operatory I Surgical
@kennethbeard5553
@kennethbeard5553 6 жыл бұрын
Linda do you have any insight or information on the (Summary) Technical Documentation (STED) or reliable sources of this detail that you able to refer me to. Either on youtube or elsewhere on the internet?
@HeartzRuler
@HeartzRuler 5 жыл бұрын
yes, you can write me at waqarlatifbutt@gmail.com
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