Комментарии:
Well described. Could you please tell me about MDCG and how they are going to help manufacturer?
ОтветитьThanks, good overview
ОтветитьNice overview.
What I see missing is the mapping between the Software as Medical Device and the Rule 11 of the MDR.
If you have a product both in the European and U.S. market is now difficutl to understand e..g if you softare is class IIb or Class III.
The unclear point is about the "death" or "irreversible" health state of the patient. This is not covered by SaMD...
Do you have suggestions about?
can I get a hard copy for this presentation
ОтветитьAre these 3 items considered as medical devices?:
Milling machines for dentists?
3D printers?
3D dental scaners ( not Intra Oral)
Resins for dentists?
Otherwise how are they classified?
Thank you so much
thanks
ОтветитьThanks for a great video! Could you further explain why it will be a disaster for startups & a killer of innovation ?
ОтветитьYou are great . Thanks for this videos ... I am an Arab engineer learning English
Ответитьcould you tell me 42/EEC means?
ОтветитьCould you please tell me, in
MDR 2017/745, what does 745 indicates?
what do you think where to next for the medical device industry?
ОтветитьNice video, My dad has been using Blucon Nightrider CGM and FreeStyle Libre for blood glucose monitoring. He gets glucose updates on his phone and watch too in every 5 minutes without fingerprick. The app gives alarm notification when blood glucose goes up and down. Also, I monitor his blood glucose from any place through Ambrosia Followblucon app. It's a great cgm.
ОтветитьGreat explanation!! Thank you
ОтветитьGreat. You are great. Thanks for this video
ОтветитьWay of presentation Excellent Sir Pls share same for IVDR 746
ОтветитьThanks sir
very useful informations.