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MedicalRegsdotCom
@medicalregsdotcom606Subscribers27
Views2.6K
Videos28
Last updatedlast month
MedicalRegsdotComPublished at March 20, 2021 at 08:50 PM1:21
New to EU MDR?
5 years agoLong-tail
newmdr
Published time
March 20, 2021 at 08:50 PM
Duration
1:21
Video type
-
Channel region
-
Publish Timing Insight
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Views
7
Likes
0
Comments
0
Estimated Daily Revenue
-
Estimated Total Revenue
$0 - $0.02
RPM Range
$0.6 - $3.5
1D Views Gain
0
7D Views Gain
0
1D Likes Gain
0
7D Likes Gain
0
1D Comments Gain
0
7D Comments Gain
0
Velocity Score
0%
Topic Cluster
new
Video Description
? New to #MDR?
Here are the critical elements in layman's terms :) ☑️ #ISO13485 #QMS - So you can consistently design and manufacture your medical devices based on requirements.
☑️ #PMS - So you can analyze post-certification/market safety and performance data and then compare it to pre-market data and report accordingly based on classification (i.e., #PSUR).
#Vigilance is a reactive approach and part of the PMS.
☑️ #UDI - So you and others can uniquely track/trace your device in the market.
☑️ #EUDAMED - So you and other parties (economic operators, NBs, competent authorities, etc.)
can obtain information on your device from a central location.
☑️ #AR - So you can have an #EU market #regulatory representation as a foreign manufacturer.
☑️ #Clinical Evaluation - So you can assess the clinical safety and performance of your device before certification.
☑️ #PMCF - So you can proactively assess the clinical safety and performance of your device and compare it to pre-market clinical evaluation.
❗️ ❕ ❓ ❔ Did I leave anything out?
Please comment to expand or correct each item I have listed above.
Thanks.
? Clarity from design to market™️ MedicalRegs ?
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