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 !!!!!!
Chapter -5 | Part-4|Validity of Import license MD 15 |Import License|L-13|CDSCO MDR 2017 regulation
Chapter -5 | Part-3|Grant of Import license MD 15 |Import License|L-12|CDSCO MDR 2017 regulation
Chapter -5 | Part-2 | Inspection of Overseas Manufacturing Site|Import License|L-11|CDSCO MDR 2017
Chapter -5 | Part-1 | Import of Medical Device Import License Application|L-10|CDSCO MDR 2017
Create Account for Establishment Registration & Device Listing USFDA-L-4 Step to Create User Account
Pay Fees for Establishment Registration and Device Listing USFDA|L-3|USFDA Fees Payment for IVDs
Chapter -4 | Part-4 | Manufacture of Medical Device for Sale or For Distribution |L-9|CDSCO MDR 2017
Chapter -4 | Part-3 | Manufacture of Medical Device for Sale or For Distribution |L-8|CDSCO MDR 2017
Chapter -4 | Part-2 | Manufacture of Medical Device for Sale or For Distribution |L-7|CDSCO MDR 2017
Chapter -4 | Part-1 | Manufacture of Medical Device for Sale or For Distribution |L-6|CDSCO MDR 2017
Process of Establishment Registration and Device Listing USFDA|L-2|Steps By Step Easy Process
Introduction to USFDA Regulation of Medical Devices |L-1| What is USFDA Regulation of Medical Device
Online Payment to CDSCO via Sugam Web Portal |CDSCO Online Payment| CDSCO Bharatkosh Payment Channel
Chapter -3 | Part-2 | Notified Body -Authorities, Officers and Bodies I CDSCO MDR 2017 | IVDs| L-5
Chapter -3 | Part-1 | Notified Body -Authorities, Officers and Bodies I CDSCO MDR 2017 | IVDs| L-5
Chapter -2 Regulation of Medical Device- Medical Device Rules 2017 |Indian CDSCO MDR 2017|IVDs| L-3
Chapter -1- Indian Medical Device Rules , 2017 |Indian CDSCO MDR 2017| IVDs| L-2
The Origin of the Indian Medical Device Rules, 2017|Indian CDSCO MDR 2017| IVDs| Medical Device
Run Pregnancy Diagnostic Test in Just 50 Seconds | Pregnancy Dipstick Test| In vitro diagnostic Test
Top IVD Companies To make Career in India| Biotech Graduate career in IVD Manufacturing Companies
Building the Perfect Organization Chart for ISO 13485 Compliance| ISO 13485 Organization Organogram
Calculate Stability Days via Excel : Accelerated Stability Studies of an IVD Product in 10 Minutes!!
Annex-3 (MD) of SFDA Medical Device Registration Process|Saudi Food & Drug Authority L-6
Annex-2 (IVD) of SFDA Medical Device Registration Process|Saudi Food & Drug Authority L-5
Annex-1 ( MD) of SFDA Medical Device Registration Process|Saudi Food & Drug Authority L-4
Process Flow Chart for SFDA Medical Device Registration Process|Saudi Food & Drug Authority L-3
Root Cause Analysis (RCA) for ISO 13485 Nonconformities | 5 Why Analysis | Fish Bone Diagram|CAPA !!
Material Handling in Daily Operations| Machine for Handling of Goods in WareHouse & Logistic Area
ISO 13485:2016 Medical Device -QMS|Clause 8.1 Measurement , analysis and improvement |L-13
MOHAP Portal Navigation: A Beginner's Guide|Navigating with Ease|Unlock Step-by-Step Tutorial U.A.E