Medical Devices classification as per FDA | Medical Device Regulations |

  ะ ะตั‚ า›ะฐั€ะฐะปะดั‹ 60,609

Digital E-Learning

Digital E-Learning

ะšาฏะฝ ะฑาฑั€ั‹ะฝ

Devices are classified into one of three regulatory classes: class I, class II, or class III. Watch the video for more details and share it with all your friends on social media.
โฑ๏ธ ๐‘ป๐’Š๐’Ž๐’† ๐‘บ๐’•๐’‚๐’Ž๐’‘ โฑ๏ธ
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0:00 - Introduction
๐Ÿ“– ๐๐ž๐ฌ๐ญ ๐๐จ๐จ๐ค ๐จ๐ง ๐€๐ฆ๐š๐ณ๐จ๐ง ( ๐ŸŽญ ๐Œ๐ฎ๐ฌ๐ญ ๐‘๐ž๐š๐ )
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๐Ÿšฉ ๐–๐จ๐ซ๐ฅ๐โ€™๐ฌ ๐†๐ซ๐ž๐š๐ญ๐ž๐ฌ๐ญ ๐๐จ๐จ๐ค๐ฌ ๐…๐จ๐ซ ๐๐ž๐ซ๐ฌ๐จ๐ง๐š๐ฅ ๐†๐ซ๐จ๐ฐ๐ญ๐ก & ๐–๐ž๐š๐ฅ๐ญ๐ก
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๐Ÿšฉ ๐๐ž๐ ๐ข๐ง๐ง๐ž๐ซ'๐ฌ ๐†๐ฎ๐ข๐๐ž ๐ญ๐จ ๐‹๐ž๐š๐ง ๐’๐ข๐ฑ ๐’๐ข๐ ๐ฆ๐š
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๐Ÿšฉ ๐Ÿ• ๐‡๐š๐›๐ข๐ญ๐ฌ ๐จ๐Ÿ ๐‡๐ข๐ ๐ก๐ฅ๐ฒ ๐„๐Ÿ๐Ÿ๐ž๐œ๐ญ๐ข๐ฏ๐ž ๐๐ž๐จ๐ฉ๐ฅ๐ž
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๐Ÿšฉ ๐‹๐ž๐š๐ง ๐’๐ข๐ฑ ๐’๐ข๐ ๐ฆ๐š ๐š๐ง๐ ๐Œ๐ข๐ง๐ข๐ญ๐š๐› - ๐‚๐จ๐ฆ๐ฉ๐ฅ๐ž๐ญ๐ž ๐ ๐ฎ๐ข๐๐ž
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๐Ÿšฉ ๐‹๐ž๐š๐ง ๐’๐ข๐ฑ ๐’๐ข๐ ๐ฆ๐š ๐…๐จ๐ซ ๐ƒ๐ฎ๐ฆ๐ฆ๐ข๐ž๐ฌ
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๐Ÿšฉ ๐‹๐ž๐š๐ง ๐๐ซ๐จ๐๐ฎ๐œ๐ญ๐ข๐จ๐ง ๐’๐ข๐ฆ๐ฉ๐ฅ๐ข๐Ÿ๐ข๐ž๐: ๐–๐จ๐ซ๐ฅ๐'๐ฌ ๐Œ๐จ๐ฌ๐ญ ๐๐จ๐ฐ๐ž๐ซ๐Ÿ๐ฎ๐ฅ ๐๐ซ๐จ๐๐ฎ๐œ๐ญ๐ข๐จ๐ง ๐’๐ฒ๐ฌ๐ญ๐ž๐ฆ
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๐Ÿ“ข๐Ÿ“ข ๐Ÿ“ข๐Ÿ“ข ๐…๐จ๐ฅ๐ฅ๐จ๐ฐ๐ฌ ๐ฎ๐ฌ ๐จ๐ง ๐‘บ๐’๐’„๐’Š๐’‚๐’ ๐‘ด๐’†๐’…๐’Š๐’‚
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๐Ÿฆ๐“๐ฐ๐ข๐ญ๐ญ๐ž๐ซ : / digitalelearni1
๐Ÿ“ธ ๐ˆ๐ง๐ฌ๐ญ๐š๐ ๐ซ๐š๐ฆ : / digital_elearning
๐Ÿ“ฉ ๐“๐ž๐ฅ๐ž๐ ๐ซ๐š๐ฆ : t.me/digital_e_learning007
๐Ÿ™‹๐Ÿปโ€โ™‚๏ธ ๐๐ข๐ง๐ญ๐ซ๐ž๐ฌ๐ญ: / digitalelearning007
๐Ÿ™‹๐Ÿปโ€โ™‚๏ธ ๐‹๐ข๐ง๐ค๐ž๐๐ˆ๐ง ๐๐š๐ ๐ž: / 55180987
๐Ÿ™‹๐Ÿปโ€โ™‚๏ธ ๐…๐š๐œ๐ž๐›๐จ๐จ๐ค ๐๐š๐ ๐ž : / digitalelearni1
๐Ÿ’Œ ๐‘ช๐’๐’๐’•๐’‚๐’„๐’• ๐’–๐’” : digital.e.learning007@gmail.com for any business/ promotion queries.
โœ๏ธ ๐““๐“ฒ๐“ผ๐“ฌ๐“ต๐“ช๐“ฒ๐“ถ๐“ฎ๐“ป:
Copyright Disclaimer under section 107 of the Copyright Act of 1976, allowance is made for โ€œfair useโ€ for purposes such as criticism, comment, news reporting, teaching, scholarship, education and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. The information contained in this video is just for educational and informational purposes only and does not have any intention to mislead or violate Google and KZfaq community guidelines or policy. I respect and follow all terms & conditions of Google & KZfaq.
๐‚๐จ๐ฆ๐ฆ๐จ๐ง ๐Š๐ž๐ฒ ๐ฌ๐ž๐š๐ซ๐œ๐ก ๐ซ๐ž๐ฅ๐š๐ญ๐ž๐ ๐ญ๐จ ๐ญ๐ก๐ข๐ฌ ๐ญ๐จ๐ฉ๐ข๐œ :
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ะŸั–ะบั–ั€ะปะตั€: 73
@DigitalELearning
@DigitalELearning 5 ะถั‹ะป ะฑาฑั€ั‹ะฝ
๐Ÿ‘€ Hello Friends, ๐‰๐จ๐ข๐ง my ๐‘บ๐’๐’„๐’Š๐’‚๐’ ๐‘ด๐’†๐’…๐’Š๐’‚ ๐‘ณ๐’Š๐’๐’Œ for regular updates: ------------------------------------------------------------------------------------------------------------------ ๐Ÿ“ธ๐ˆ๐ง๐ฌ๐ญ๐š๐ ๐ซ๐š๐ฆ : instagram.com/digital_elearning/ ๐Ÿฆ๐“๐ฐ๐ข๐ญ๐ญ๐ž๐ซ: twitter.com/DigitalELEARNI1 ๐Ÿ“ข๐“๐ž๐ฅ๐ž๐ ๐ซ๐š๐ฆ : t.me/digital_e_learning007 ๐Ÿ™‹๐Ÿปโ€โ™‚๐–๐ก๐š๐ญ๐ฌ๐€๐ฉ๐ฉ (๐‹๐ž๐š๐ง ๐ฌ๐ข๐ฑ ๐ฌ๐ข๐ ๐ฆ๐š) : whatsapp.com/channel/0029VaAUuqs4inooet3e4S3O ๐Ÿ™‹๐Ÿปโ€โ™‚๐–๐ก๐š๐ญ๐ฌ๐€๐ฉ๐ฉ (๐’๐ข๐ฑ ๐’๐ข๐ ๐ฆ๐š (๐Ÿ”ฯƒ ) : whatsapp.com/channel/0029VaEWKWbIiRovZpAduc0p ๐Ÿ™‹๐Ÿปโ€โ™‚๐–๐ก๐š๐ญ๐ฌ๐€๐ฉ๐ฉ (๐’๐ญ๐š๐ญ๐ข๐ฌ๐ญ๐ข๐œ๐ฌ & ๐‘๐ž๐ฌ๐ž๐š๐ซ๐œ๐ก) :whatsapp.com/channel/0029VaAGwzTDJ6H9S5Q4Ow0m ๐Ÿ™‹๐Ÿปโ€โ™‚๐–๐ก๐š๐ญ๐ฌ๐€๐ฉ๐ฉ (๐๐ซ๐จ๐ฃ๐ž๐œ๐ญ ๐Œ๐š๐ง๐š๐ ๐ž๐ฆ๐ž๐ง๐ญ) :whatsapp.com/channel/0029Va8slQdEAKWAhXoQK13B ๐Ÿ™‹๐Ÿปโ€โ™‚๐–๐ก๐š๐ญ๐ฌ๐€๐ฉ๐ฉ (๐๐ฎ๐š๐ฅ๐ข๐ญ๐ฒ ๐€๐ฌ๐ฌ๐ฎ๐ซ๐š๐ง๐œ๐ž & ๐๐ฎ๐š๐ฅ๐ข๐ญ๐ฒ ๐‚๐จ๐ง๐ญ๐ซ๐จ๐ฅ) :whatsapp.com/channel/0029VaAKJBGKGGGDjcK4mw2h
@vivaanbo3905
@vivaanbo3905 2 ะถั‹ะป ะฑาฑั€ั‹ะฝ
I know it's kinda randomly asking but does anyone know of a good website to watch new tv shows online ?
@kelvinspencer6971
@kelvinspencer6971 2 ะถั‹ะป ะฑาฑั€ั‹ะฝ
@Vivaan Bo Flixportal :)
@vivaanbo3905
@vivaanbo3905 2 ะถั‹ะป ะฑาฑั€ั‹ะฝ
@Kelvin Spencer Thank you, I signed up and it seems to work =) Appreciate it !!
@kelvinspencer6971
@kelvinspencer6971 2 ะถั‹ะป ะฑาฑั€ั‹ะฝ
@Vivaan Bo happy to help :D
@fazil264
@fazil264 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
if you could remove the background music, would be wonderful. Thank you!
@DigitalELearning
@DigitalELearning 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Fazil thanks for your input. Unfortunately I cannot remove but yes going forward I will not add this music
@fazil264
@fazil264 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
@@DigitalELearning This was so informative. Thanks for acknowledging.
@DigitalELearning
@DigitalELearning 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Thanks for supporting
@rohan5753
@rohan5753 ะะน ะฑาฑั€ั‹ะฝ
nice informative video
@DigitalELearning
@DigitalELearning ะะน ะฑาฑั€ั‹ะฝ
Thanks ๐Ÿ‘
@rajatkohli7141
@rajatkohli7141 5 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Nice content beautifully explained . Understood all. Thank you for sharing this
@DigitalELearning
@DigitalELearning 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Thanks for watching.. ๐Ÿ˜€๐Ÿ“บ
@TheShubhamdel06
@TheShubhamdel06 2 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Very nicely explained in a short time. Got some basic info. Thank you so much
@DigitalELearning
@DigitalELearning 2 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Glad it was helpful! Thanks ๐Ÿ˜Ž
@anoopbaghel7866
@anoopbaghel7866 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Whether infectious disease positive serum like HIV, HBV, HCV positive serum which are to be supplied to the IVD kits manufacturer are regulated in EUROPE and other GHTF countries..?
@velmuruganp9255
@velmuruganp9255 4 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Sir for non medical products do we need any licence to run the shop and what type of licence we have to take for sales
@dayabachala2859
@dayabachala2859 ะ–ั‹ะป ะฑาฑั€ั‹ะฝ
Hi, Thank you for the Info. Could you please share any sample PMS Plans or PMSR templates done as per 21CFR?
@shilpatil29
@shilpatil29 2 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Very nice explanation for beginners, thanks for sharing ๐Ÿ‘
@DigitalELearning
@DigitalELearning 2 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Glad you liked it
@rajatkohli7141
@rajatkohli7141 5 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Thanks you for sharing
@DigitalELearning
@DigitalELearning 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Thanks
@lopeztaylor994
@lopeztaylor994 5 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Great job.
@DigitalELearning
@DigitalELearning 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Thanks
@gorakhghuge6522
@gorakhghuge6522 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Very nice information. Thank you..
@DigitalELearning
@DigitalELearning 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Thanks Gorakh
@sumantiwari4985
@sumantiwari4985 7 ะฐะน ะฑาฑั€ั‹ะฝ
Thanks a lot ๐Ÿ™๐Ÿป
@DigitalELearning
@DigitalELearning 7 ะฐะน ะฑาฑั€ั‹ะฝ
You're welcome ๐Ÿ˜Š
@nainamdixit9720
@nainamdixit9720 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
I also need some sample document related to iso 14971 , can you please support . Thanks
@himanshiarora7681
@himanshiarora7681 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
nice video please upload more videos on regulatory affairs syllabus
@DigitalELearning
@DigitalELearning 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Sure Himanshi
@ayonghosh8478
@ayonghosh8478 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Nice Vedio,,
@DigitalELearning
@DigitalELearning 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Thanks Ayon
@stdioconio999
@stdioconio999 2 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Spectacle glasses will fall under which class and does class I have further sub categories?
@DigitalELearning
@DigitalELearning 2 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Class 1 device and there is no further sub category
@vmangoli
@vmangoli ะ–ั‹ะป ะฑาฑั€ั‹ะฝ
Hello, do you help completing medical device licencing formalities?
@DigitalELearning
@DigitalELearning ะ–ั‹ะป ะฑาฑั€ั‹ะฝ
No Sorry
@monetpiedad7611
@monetpiedad7611 2 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Hello. Can we import medical devices even if we are not a medical company?
@DigitalELearning
@DigitalELearning 2 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Probably yes but need some lisence to import
@vijaykiran2167
@vijaykiran2167 4 ะถั‹ะป ะฑาฑั€ั‹ะฝ
hi is there any video in IEC 62304
@DigitalELearning
@DigitalELearning 4 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Hi Vijay, as it is not there but I will definitely add it soon
@harshitrastogi2473
@harshitrastogi2473 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Sir you hv to make another video because background music disturb as well as down your voice
@DigitalELearning
@DigitalELearning 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Sure will work on your feedback
@avinashsokhi942
@avinashsokhi942 2 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Hi, a question at 4:26 They are 510kc...what is kc?
@DigitalELearning
@DigitalELearning 2 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Hi Avinash, this was a typo. It 510k only
@bhaveshchoudhary8421
@bhaveshchoudhary8421 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Sir manufacturing medical device open Karne ke liye b.pharm is enough or we have to do m.pharm ?
@DigitalELearning
@DigitalELearning 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
This is a regualted industry , definately just having this is not enough. There may be other requirments You can check the web for same
@bhaveshchoudhary8421
@bhaveshchoudhary8421 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
@@DigitalELearning thank u sir
@umamaheswari1129
@umamaheswari1129 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
is it need any special qualification to start this
@DigitalELearning
@DigitalELearning 2 ะถั‹ะป ะฑาฑั€ั‹ะฝ
To start what ? Can you be more specific
@nainamdixit9720
@nainamdixit9720 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Nice video , may I have the list of restticted material for the material compliance .
@DigitalELearning
@DigitalELearning 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Nainam, I dont have that handy but you can check that in google. If I find anything I will reply here
@nainamdixit9720
@nainamdixit9720 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
@@DigitalELearning ok thanks
@adithyaasrinivaas1445
@adithyaasrinivaas1445 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Good info...but, pls stop the background music ...your voice is not audible bit
@DigitalELearning
@DigitalELearning 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Feedback noted
@sujayd7142
@sujayd7142 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Nice video but the sound and the floating images are distracting makes it hard to concentrate. Can you please try to reduce that. People have difficulty focussing so things like this distract people even more.
@DigitalELearning
@DigitalELearning 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Sure will work on this
@HamzaHajeir
@HamzaHajeir 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
nice content, but lot of noise is out there
@DigitalELearning
@DigitalELearning 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Thanks ...will work on this feedback
@srikarsarakallu2607
@srikarsarakallu2607 2 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Pl remove background music, its not clear with the music
@DigitalELearning
@DigitalELearning 2 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Feedback Noted
@finmaxx
@finmaxx 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
The music makes it hard to hear . No music more subscribers
@DigitalELearning
@DigitalELearning 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Feedback noted โœ…
@zakariahlafreniere1332
@zakariahlafreniere1332 2 ะถั‹ะป ะฑาฑั€ั‹ะฝ
is this in Chinese?
@DigitalELearning
@DigitalELearning 2 ะถั‹ะป ะฑาฑั€ั‹ะฝ
No
@saurabhsonawane1683
@saurabhsonawane1683 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Please remove advertisement
@DigitalELearning
@DigitalELearning 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Feedback noted. Thanks :)
@jenran39
@jenran39 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
He is talking way too fast and that music is distracting... I couldn't watch it
@DigitalELearning
@DigitalELearning 3 ะถั‹ะป ะฑาฑั€ั‹ะฝ
Feedback notes
Medical Device Regulations / FDA Approval
9:28
The BME Life
ะ ะตั‚ า›ะฐั€ะฐะปะดั‹ 32 ะœ.
ISO 14971 : 2019 ( Medical Device Risk management ) | Detailed explanation Clause by Clause
25:39
Digital E-Learning
ะ ะตั‚ า›ะฐั€ะฐะปะดั‹ 22 ะœ.
ะญั‚ะพั‚ ะŸั‘ั ะšะพะต-ะงั‚ะพ ะะฐะดะตะปะฐะป ๐Ÿ˜ณ
00:31
ะ“ะปะตะฑ ะ ะฐะฝะดะฐะปะฐะนะฝะตะฝ
ะ ะตั‚ า›ะฐั€ะฐะปะดั‹ 4,2 ะœะ›ะ
์•„์ด์Šคํฌ๋ฆผ์œผ๋กœ ์ฒด๊ฐ๋˜๋Š” ์š”์ฆ˜ ๋ฌผ๊ฐ€
00:16
์ง„์˜๋ฏผyeongmin
ะ ะตั‚ า›ะฐั€ะฐะปะดั‹ 56 ะœะ›ะ
How Many Balloons Does It Take To Fly?
00:18
MrBeast
ะ ะตั‚ า›ะฐั€ะฐะปะดั‹ 139 ะœะ›ะ
Introduction to different classifications rules for medical device software
12:24
Medical Device HQ
ะ ะตั‚ า›ะฐั€ะฐะปะดั‹ 2,2 ะœ.
FDA 101 for Medical Devices
57:47
Registrar Corp
ะ ะตั‚ า›ะฐั€ะฐะปะดั‹ 35 ะœ.
Short course on the Medical Device Regulation (EU) 2017/745
14:55
Medical Device HQ
ะ ะตั‚ า›ะฐั€ะฐะปะดั‹ 28 ะœ.
Classification Medical Device in EU (Medical Device Regulation MDR 2017/745)
8:23
Easy Medical Device
ะ ะตั‚ า›ะฐั€ะฐะปะดั‹ 35 ะœ.
Electrical Safety Of Medical Equipment's | Biomedical Engineers TV |
7:47
Biomedical Engineers TV
ะ ะตั‚ า›ะฐั€ะฐะปะดั‹ 31 ะœ.
FDA Process for Medical Device Startups: an Investor's Point of View
56:55
The University of Chicago Booth School of Business
ะ ะตั‚ า›ะฐั€ะฐะปะดั‹ 2,4 ะœ.
What is a Class 1 and 2 device exemption?
12:06
Medical Device Academy
ะ ะตั‚ า›ะฐั€ะฐะปะดั‹ 1 ะœ.
ISO 13485: What You Need to Know to Build a Quality Management Systems for Medical Devices
13:11
ZimmerPeacock
ะ ะตั‚ า›ะฐั€ะฐะปะดั‹ 4,8 ะœ.
21 CFR Part 820 - Quality System Regulation | 21 CFR 820.30 Medical Device Design Control Guidelines
12:04
Digital E-Learning
ะ ะตั‚ า›ะฐั€ะฐะปะดั‹ 20 ะœ.
Developing a Testing Plan for Medical Device Design Verification
29:27
Eurofins Medical Device Testing
ะ ะตั‚ า›ะฐั€ะฐะปะดั‹ 22 ะœ.