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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Chapter -5 | Part-5|Condition to be complied by Import License Holder|L-14|CDSCO MDR 2017 regulation
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ISO 13485:2016 Medical Device -QMS|Clause 4 Quality Management System (QMS) for Medical Devices |L-4
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