IVDR implementation during the uncertain time of Corona Pandemic remains challenging.
Almost all organizations were forced to adjust/delay the IVDR program implementation. The whole process of Implementation became challenging due to compulsory home office rules, focus shift to Corona Tests, lack of notified bodies, Reference labs, and Audits (Internal and external).
During this course, we will present a case study on the IVDR implementation on a diagnostic device to fight COVID-19.
Dr. Krutarth Patel works at R-Biopharm AG in Germany as a Vice President for QM / RA, he has more than 10 years of experience In Vitro Diagnostics with hands on experience with ISO 13485, ISO 9001 and MDSAP, Council Directives In Vitro Diagnostics IVDD 98/79/EC and IVDR. Dr. Patels had various positions during his professional career in IVD industries e.g. marketing & Sales, Clinical Affairs, Product Management, R&D, Production and as an Auditor.
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