IVD MANUFACTURING
IVD Professional |🥇 Gold Medalist|IVD You-tuber 📢📸|Experience in the Medical Device Plant Set Up|Production|R&D|Operations|Quality Assurance|Regulatory Affairs|MD-QMS|WHO-PQ|ISO 13485|MDSAP|Lean Manufacturing
IVD Professional with 11+ years experience in Operations , Factory Set Up , WHO-PQ Submission , Regulatory Submission ,Manufacturing and Designing of -
1.) Lateral & Flow Through Technique based product’s (Malaria,Dengue NS1 ,Syphilis ,Fertility , Ovulation ,Urine Test Strips with different Parameters )
2.) Serology Based Product’s ( CRP Slide Latex , RFA Slide Latex , CRP & RFA Turbilatex )
3.) Bio-Chemistry Based Product’s ( Protein Biuret , Triglyceride’s , Alkaline Phosphatase ,Creatinine , SGOT , SGPT ,Glucose)
4.) Clinical Chemistry ( Diluent , Lysine )
5.) Molecular Diagnostics (RT-PCR)
ISO13485:2016 , ISO9001:2015,ISO14971:2019,EUIVDR ,MDR2017,CE Marking ,MDSAP,Statutory Compliance,Lean Manufacturing,Automation Handling
LETS LEARN TOGETHER AND GROW TOGETHER !!!!!!
IVD MANUFACTURING
1 year ago | [YT] | 2
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IVD MANUFACTURING
Hello Connections ....
Are you really interested in knowing about US FDA 510(k) Clearance Process then wait is over....
Upcoming Video on 510(k) Clearances-FDA|Premarket Notifications 510(k)|510(k) Submission Process|Medical Device Entry| stay tuned on my channel to be published on 25/08/2024 @ 12:00 IST... 💉
1 year ago | [YT] | 3
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IVD MANUFACTURING
For my lovely subscribers ....
1 year ago | [YT] | 3
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IVD MANUFACTURING
True but more often ...
1 year ago | [YT] | 1
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IVD MANUFACTURING
Launch of National Single Window System (NSWS) Portal by CDSCO.
Existing Portal to get disabled with immediate effect from 15/01/2024 for MD-01,MD-12 & MD-16.
#cdsco
#medicaldevices
#ivd
2 years ago | [YT] | 2
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IVD MANUFACTURING
Happy Diwali to all my lovely subscribers.....
2 years ago | [YT] | 3
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IVD MANUFACTURING
Follow the I.V.D Manufacturing channel on
WhatsApp: whatsapp.com/channel/0029Va95z5MEgGfUUXGlTB3Y
2 years ago | [YT] | 2
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IVD MANUFACTURING
Top 10 Q.A which can bring manufacturers very close to Customers.Which means delivering Product or Services following the SQDC Principle.
#Safety
#Quality
#Delivery
#Cost
2 years ago | [YT] | 3
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IVD MANUFACTURING
Good Morning Connection ,
As per new CDSCO Notification/ circular relaxation have been provided for
additional 6 months to import/ manufacture Class C&D MD by those manufacturers who have applied either the import or manufacturing license application.
Let's gear up Manufacturers .
#CDSCO
#IVD
#MEDICAL DEVICE
‪@ivdmanufacturing7208‬
2 years ago | [YT] | 1
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IVD MANUFACTURING
Is the Quality Manual Outcome of Quality Policy as per ISO13485:2016
2 years ago | [YT] | 4
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