ISO 14971 : 2019 ( Medical Device Risk management ) | Detailed explanation Clause by Clause

[@DigitalELearning]

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[@rinkyranhotra5671]

Thank you for updates on ISO 14971 : 2019 edition

[@DigitalELearning]

Thanks

[@emy484]

Great work1 thanks for putting it out, concise and apt!

[@DigitalELearning]

Glad you enjoyed it!

[@veerendrapateelcs6042]

Clearly and well explained Thank you sir

[@DigitalELearning]

Thanks Veerendra .Glad you liked it. Kepp watching

[@rajeevpratapsingh7460]

Hi, the video explains the basic concept in very clear and concise ways. I just want to ask that who makes these risk evaluation matrix? is that matrix same or differs from company to companies?

[@sofiyak2544]

Really needed the updates. Thank you so much

[@prakashmehta9243]

Thanks

[@DigitalELearning]

Thanks

[@manjumandre4430]

Well explained, Keep explaining more things😊

[@DigitalELearning]

Thank you, I will . I appreciate that! Thank You

[@navjyotigorai780]

Thanks for the Update.

[@DigitalELearning]

Thanks for watching . I hope you find it worth it :)

[@baygones1]

Useful update 👍

[@DigitalELearning]

Thanks Mini Glad you think so!

[@amitkumarkp6834]

Thanks a lot.

[@DigitalELearning]

Welcome 😊

[@sarathavenkadesh1050]

Excellent one!

[@DigitalELearning]

Glad you like it!

[@rahulghosh5725]

Helpfull thank you❤

[@DigitalELearning]

You’re welcome 😊

[@avinashsokhi942]

Simply fantastic ☺️

[@DigitalELearning]

Thanks a lot 😊

[@S_kumar_official_]

🙏 Thank you

[@DigitalELearning]

Welcome!

[@dr.alsharma3549]

Nice presentation. Well explained

[@DigitalELearning]

Thanks

[@ramjichandran5115]

thanks👍

[@DigitalELearning]

Welcome

[@liboyu9771]

Excellent 👍

[@DigitalELearning]

Thank you! Cheers!

[@hobber_]

So very useful thx!

[@DigitalELearning]

Thanks Hobber 😎

[@ektasingh8945]

Very clear

[@MrAmerican1988]

Hi can you clarify what was covered in Clause 2 Normative Reference. Thanks and I found this to be very useful

[@woodeye6699]

Clause 2 Normative References was required to be added by ISO, even though there are no Normative References (other standards that are required). That is required by the ISO structure for standards and we had not included it in previous editions because the confusion it caused by listing "none" just as you have discovered. It also had to be added as Clause 2, because that is the rules for ISO standards. It required the numbering for the clauses to be changed from the previous editions, causing more confusion. The previous Clause 2 was "Terms and Definitions", it is now Clause 3, and so on....

[@DigitalELearning]

Thanks for clariying

[@DigitalELearning]

Thanks

[@karthikmandadi85]

Nice presentation. Can you do a video on IQ, OQ, PQ for a medical equipment?

[@DigitalELearning]

Kartik. I have already made a video on IQ OQ PQ lasr year. You can check on my UA-cam channel. Also my plan is add more of such stuff in near future

[@engineeringsolutions3000]

Very Nice👍👍👍
#sandeshlaghave

[@DigitalELearning]

Thanks Sandesh

[@monalitomar7528]

Can you share pdf file for your slides ?

[@salcast738]

My apology.
Excellent content, just not used to this ascent

[@DigitalELearning]

Alright :)

[@salcast738]

Do not understand your ascent....

[@DigitalELearning]

Feedback notes

[@shamirkumardey527]

Hi

[@DigitalELearning]

Hi Shamir,

[@S_kumar_official_]

🙏 Thank you

[@DigitalELearning]

Welcome!