The 5 most relevant changes the Medical Device Regulation MDR introduces, that you must know
The Medical Device Regulation MDR replaces both, the Medical Device Directive (MDD, 93/42/EEC) and the Directive for Active Implantable Medical Devices (AIMDD).
This video gives an overview on the 5 most relevant changes the MDR introduces. These changes include
1. Conformity assessment procedures
2. Classification
3. Essential requirements – General safety and performance requirements
4. UDI & EUDAMED
5. Post-Market requirements
The Johner Institute helps medical device manufacturers to fast and easily navigate the approval processes, to fulfill the MDR requirements and to obtain the CE mark.
Complimentary consulting on www.johner-institute.com.
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Way of presentation Excellent Sir Pls share same for IVDR 746
Great. You are great. Thanks for this video
Great explanation!! Thank you
Nice 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.
what do you think where to next for the medical device industry?
Sir, Thanks indeed for medical devices comprehensive presentation.
i want to ask question: whether healthcare simulation systems like #mentice endovascular simulator, #urosim urology simulator, #lapsim laparoscopy simulator etc also required MDR regulations for their production???
Could you please tell me, in
MDR 2017/745, what does 745 indicates?
could you tell me 42/EEC means?
You are great . Thanks for this videos … I am an Arab engineer learning English
Feel free to go to my website: http://ummahsynergy.blogspot.com/ for Malaysia GDPMD and MDA Establishment License application
Thanks for a great video! Could you further explain why it will be a disaster for startups & a killer of innovation ?
Perfect…
thanks
Register medical device as per Indian regulatory body i.e. CDSCO(Central Drugs Standard Control Organization).
More details visit : https://morulaa.com/registration-services/
CDSCO Guidelines, CDSCO Approval
Are 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
can I get a hard copy for this presentation
Nice 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?
Thank you. We had implemented some software solutions with https://pro4people.com/medical-device-software-development/
. Do you think we can expect them to do some updates to keep up with new regulations?
Thanks, good overview
Well described. Could you please tell me about MDCG and how they are going to help manufacturer?