D K Email & Phone Number

Experienced, Technical and R&D -Head with 25 years of diverse experience in medical device industry. Innovations-granted or filed over 150 US, Indian, EU and international patents.Design, development and management of novel metallic, polymeric, biological tissue and local drug delivery based Class III & II medical devices in area of cardiovascular, peripheral-vascular, neurovascular, structural heart & repair, renal, ENT, paediatric and in digestive track.- To accomplish successful research, process development with commercial results under tight timeline, budge and resources.- To lead highly innovative project(s), risk assessment and validation of product & production processes.- To develop & validate new test method, execute bench test, in-vitro performance test, biocompatibility and non-clinical/ animal study for validation-products in accordance with applicable national & international standards.- To handle technology transfer & implementation of new products and existing improved-products effectively into manufacturing for commercialization- To identify & generate new intellectual property (IP) and translate novel ideas into valuable & protectable IP.- Sphere of competence to work on QMS documents, risk management, internal audit, training, FMEA, trouble-shooting and to handle regulatory queries & complex technical issues.- Post market surveillance (PMS) activity includes effective management of customer complaints, corrective action and preventive action (CAPA); non-conformities (NC), medical device report (MDR) & medical device vigilance report (MDV) to competent authority as well as post market clinical follow-up (PMCF) to obtain long term safety & functional data on medical devices from patients.- Understanding of latest MDD/43/92/EEC, ISO 13485 (2016), EN ISO 14971 (2012), ISO 10993, ISO 9001 (2015), EN 556, EN ISO 11135 & 11137, Schedule M III, 510K, 21 CFR part 820, CMDCAS 13485, KGMP, BGMP, WHO PQ, MHLW Ministerial Ordinance No. 169 (JGMP), etc.