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 !!!!!!
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Create Account for Establishment Registration & Device Listing USFDA-L-4 Step to Create User Account
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Chapter -4 | Part-4 | Manufacture of Medical Device for Sale or For Distribution |L-9|CDSCO MDR 2017
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Chapter -4 | Part-3 | Manufacture of Medical Device for Sale or For Distribution |L-8|CDSCO MDR 2017
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Chapter -4 | Part-2 | Manufacture of Medical Device for Sale or For Distribution |L-7|CDSCO MDR 2017
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Chapter -4 | Part-1 | Manufacture of Medical Device for Sale or For Distribution |L-6|CDSCO MDR 2017
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Introduction to USFDA Regulation of Medical Devices |L-1| What is USFDA Regulation of Medical Device
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Online Payment to CDSCO via Sugam Web Portal |CDSCO Online Payment| CDSCO Bharatkosh Payment Channel
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Run Pregnancy Diagnostic Test in Just 50 Seconds | Pregnancy Dipstick Test| In vitro diagnostic Test
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Calculate Stability Days via Excel : Accelerated Stability Studies of an IVD Product in 10 Minutes!!
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Root Cause Analysis (RCA) for ISO 13485 Nonconformities | 5 Why Analysis | Fish Bone Diagram|CAPA !!
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