Kunal Patel
Partner Fameux Medical Qms & Regulatory Consultant Medical Device Pharma Packaging @Fameux Medical Llp
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WORK HISTORY
Partner Fameux Medical Qms & Regulatory Consultant Medical Device Pharma Packaging @Fameux Medical Llp
Surat, IN
EDUCATION
South Gujarat University
B.Sc, Chemistry
South Gujarat University
M.Sc, Analytical Chemistry
ABOUT KUNAL PATEL
I have over 22 years’ experience in the medical device. Invitro Diagnostics sector and Pharma Packaging sector. Having working experience in high quality products brands of new start up/projects of leading companies of India as well as German Manufacturer. Hand on working exposure on various aspects of quality management system, QMS certification, Regulatory compliance, and training within the medical device, IVD & primary packaging industries. Within 22 years of career start from production chemist to QA Head to GM Operation core focus on Management System implementation inline with QMS / H&S / ISO standards lead to safe and quality products. Qualified Internal Auditor - ISO 9001Qualified Internal Auditor - ISO 13485Qualified Internal Auditor - ISO 45001\"FDA Approved Chemist\" for Chemical and Physico chemical testing.Quality Management System / Certification : ISO 9001 - ISO 15378 - ISO 45001 - ISO 13485 - WHO GMP/cGMPMedical Device Regulatory work : EU MDR | US FDA | Country Registrations | MDSAP | CE Marking | Risk assessment
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