A 4-part series of complimentary webinars on MDR
Part 2 : Packaging - Friday, 27th November, 1.30 pm PHT
Part 3 : Sterilization - Monday, 7th December, 1.30 pm PHT
Part 4 : TD Assessment - Thursday, 17th December, 1.30 pm PHT
The new Medical Device Regulation imposes strict demands on medical device manufacturers and the Notified Bodies whom they must involve in the approval process of medical devices other than self-declaration class I devices. While advanced preparation and early action is key to ensuring a smooth transition to the new requirements, medical device manufacturers are expected to encounter challenges pertaining to review and approval processes, among others.
To address these challenges, TÜV SÜD’s experts will share insights on key changes, assessment procedures and other requirements, through our ‘Fit for MDR’ series of complimentary webinars. To register for individual part of the series, please click on respective links given below.
Mr. Senthil Kumar A
Mr. Senthil Kumar A, a Master of Philosophy degree-holder in Biochemistry is an experienced toxicologist, presently working as an Auditor and Biocompatibility expert in Medical and Health Services (MHS), TÜV SÜD Products Services Division.
Mr. Senthil has been responsible for reviewing the biocompatibility assessment and toxicological risk assessments across TÜV SÜD South Asia, and has gained good knowledge in Pharmacology and Toxicology through his professional experience in various organizations as a researcher and study director in various in vivo efficacy and toxicological studies.
His experience in the field of Non-clinical overview, Toxicological profile, CTD, Toxicological / safety assessment for cosmetics and OTC products has helped him build a strong knowledge base in Biocompatibility Assessment of medical devices.
Mr. Neppo Anand
Mr. Neppo Anand brings with him a rich industry experience of over 21 years. His expertise lies primarily in the field of medical devices and pharma packaging.
Mr. Anand is a PVP MSc degree holder in Applied Microbiology and has worked extensively across the pharmaceutical industry as a Quality Management System (QMS) professional.
Presently working as a lead auditor, he is also responsible for TD reviews, high risk product sterilization and packaging at TÜV SÜD’s Product Services division in India.
The Packaging module under MDR captures a holistic insight on the expectations by the Notified Body, in order to understand the documentation for the usability evaluation of the sterile barrier system.
The Sterilization module under MDR covers a comprehensive discussion about EO residuals, in relation to patient population.
This module aims to provide a holistic understanding on the Technical Documentation Assessment according to Annex IX Chapter II.