Medical Devices classification as per FDA | Medical Device Regulations |

[@DigitalELearning]

👀 Hello Friends, 𝐉𝐨𝐢𝐧 my 𝑺𝒐𝒄𝒊𝒂𝒍 𝑴𝒆𝒅𝒊𝒂 𝑳𝒊𝒏𝒌 for regular updates:
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[@vivaanbo3905]

I know it's kinda randomly asking but does anyone know of a good website to watch new tv shows online ?

[@kelvinspencer6971]

@Vivaan Bo Flixportal :)

[@vivaanbo3905]

@Kelvin Spencer Thank you, I signed up and it seems to work =) Appreciate it !!

[@kelvinspencer6971]

@Vivaan Bo happy to help :D

[@fazil264]

if you could remove the background music, would be wonderful. Thank you!

[@DigitalELearning]

Fazil thanks for your input. Unfortunately I cannot remove but yes going forward I will not add this music

[@fazil264]

@@DigitalELearning This was so informative. Thanks for acknowledging.

[@DigitalELearning]

Thanks for supporting

[@rajatkohli7141]

Nice content beautifully explained . Understood all. Thank you for sharing this

[@DigitalELearning]

Thanks for watching.. 😀📺

[@rohan5753]

nice informative video

[@DigitalELearning]

Thanks 👍

[@shilpatil29]

Very nice explanation for beginners, thanks for sharing 👍

[@DigitalELearning]

Glad you liked it

[@sumantiwari4985]

Thanks a lot 🙏🏻

[@DigitalELearning]

You're welcome 😊

[@TheShubhamdel06]

Very nicely explained in a short time. Got some basic info. Thank you so much

[@DigitalELearning]

Glad it was helpful! Thanks 😎

[@anoopbaghel7866]

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..?

[@himanshiarora7681]

nice video please upload more videos on regulatory affairs syllabus

[@DigitalELearning]

Sure Himanshi

[@ayonghosh8478]

Nice Vedio,,

[@DigitalELearning]

Thanks Ayon

[@dayabachala2859]

Hi, Thank you for the Info. Could you please share any sample PMS Plans or PMSR templates done as per 21CFR?

[@gorakhghuge6522]

Very nice information. Thank you..

[@DigitalELearning]

Thanks Gorakh

[@harshitrastogi2473]

Sir you hv to make another video because background music disturb as well as down your voice

[@DigitalELearning]

Sure will work on your feedback

[@velmuruganp9255]

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

[@nainamdixit9720]

I also need some sample document related to iso 14971 , can you please support . Thanks

[@rajatkohli7141]

Thanks you for sharing

[@DigitalELearning]

Thanks

[@lopeztaylor994]

Great job.

[@DigitalELearning]

Thanks

[@stdioconio999]

Spectacle glasses will fall under which class and does class I have further sub categories?

[@DigitalELearning]

Class 1 device and there is no further sub category

[@vmangoli]

Hello, do you help completing medical device licencing formalities?

[@DigitalELearning]

No Sorry

[@sujayd7142]

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]

Sure will work on this

[@adithyaasrinivaas1445]

Good info...but, pls stop the background music ...your voice is not audible bit

[@DigitalELearning]

Feedback noted

[@bhaveshchoudhary8421]

Sir manufacturing medical device open Karne ke liye b.pharm is enough or we have to do m.pharm ?

[@DigitalELearning]

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]

@@DigitalELearning thank u sir

[@monetpiedad7611]

Hello. Can we import medical devices even if we are not a medical company?

[@DigitalELearning]

Probably yes but need some lisence to import

[@avinashsokhi942]

Hi, a question at 4:26 They are 510kc...what is kc?

[@DigitalELearning]

Hi Avinash, this was a typo. It 510k only

[@nainamdixit9720]

Nice video , may I have the list of restticted material for the material compliance .

[@DigitalELearning]

Nainam, I dont have that handy but you can check that in google. If I find anything I will reply here

[@nainamdixit9720]

@@DigitalELearning ok thanks

[@srikarsarakallu2607]

Pl remove background music, its not clear with the music

[@DigitalELearning]

Feedback Noted

[@vijaykiran2167]

hi is there any video in IEC 62304

[@DigitalELearning]

Hi Vijay, as it is not there but I will definitely add it soon

[@umamaheswari1129]

is it need any special qualification to start this

[@DigitalELearning]

To start what ? Can you be more specific

[@finnnnma]

The music makes it hard to hear . No music more subscribers

[@DigitalELearning]

Feedback noted ✅

[@HamzaHajeir]

nice content, but lot of noise is out there

[@DigitalELearning]

Thanks ...will work on this feedback

[@zakariahlafreniere1332]

is this in Chinese?

[@DigitalELearning]

No

[@saurabhsonawane1683]

Please remove advertisement

[@DigitalELearning]

Feedback noted. Thanks :)

[@jenran39]

He is talking way too fast and that music is distracting... I couldn't watch it

[@DigitalELearning]

Feedback notes