He has experience in Quality System Audits & Consultancy for CE Certification for all Class of Sterile/ Non-sterile Medical Devices. He also has experience in US FDA 510 k CDRH regulatory submissions for Medical Devices & PMA. He has more than 10 years experience in projects related to international technology transfers and setting up new plants for medical devices like Coronary stents, Drug Eluting stents, Ophthalmic Implants (IOL), Orthopaedic implants, IUDs etc.

He has designed & executed DQ, IQ, OQ, PQ validations, process validation for sterilization and stability studies and Plant design to comply with international requirements. He has worked on various stages of regulatory submissions including biocompatibility, pre-clinical & clinical studies. He has been a Consultant for UNIDO cluster program for QMS & CE marking of Medical Devices and Bio Pruner Mentor with EDI & MSME Cluster.

He has widely travelled in USA, Canada, Europe, China, UAE for consultations / Audits / executing projects; attending conferences and technical presentations.

He has been a Speaker at various WHO-GMP WORKSHOPS - NEW DELHI/HYDERABAD and also served as member of first Core group of DCGI (Indian FDA) for Medical Device Regulations revision.

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Ms. Swarna Sundar
Senior Consultant - Healthcare Frost & Sullivan,
Mumbai

She graduated from University of Madras, Chennai and has done Masters in Applied Science from Dalhousie University, Canada.

She has Functional Expertise of 11+ years of market research & analysis and applying customized research and analytical solutions in diverse healthcare domains on a global scale. She has Particular expertise in Competitive intelligence, Acquisition due diligence, and Value proposition; Market assessment, modeling and trend forecasting; New product development and launch strategies; Develop market entry and expansion strategies.

She has experience in broad range of sectors, including Advanced Medical Technologies; surgical and patient monitor technologies; Emerging Medical Technologies / Next-generation Healthcare; In-vitro Diagnostics; Consumer healthcare and general healthcare system trends market.

She has worked with prominent companies in medical devices and technologies market, like GE Healthcare, Phillips Healthcare, Siemens Medical, Medtronic, Johnson & Johnson, among others.

She has Published her work (s) on Diagnosis of Carpal Tunnel Syndrome in peer-reviewed journals and presented at international conferences.

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Mr. Ravi Shankar Srivastava
Chairman & MD
Invent Bio-Med Pvt. Ltd., Mumbai

Mr. Ravi Shankar Srivastava is Chairman & MD of Invent Bio-Med Pvt. Ltd., Mumbai.

Mr. Srivastava is B.sc (Hons) Diploma in Business development, certificate on Biotechnology from SIS Institute, Government of India. He has also done MBA (Marketing) and completed OMP4 one year post graduate management program from SPJIM, Mumbai.

He has worked in multinational pharmaceutical company at senior level. He has also worked in Pfizer (Schneider) medical device company of Switzerland, & took training in Australia, Singapore, Paris, Toulouse.

He has participated & attended many international cardiology and interventional therapeutics programs and trainings. He has also attended national workshop on medical device regulations.

He started trading company initially at Mumbai. Then he expanded to manufacturing, under the name of Invent Bio-Med Pvt. Ltd., at Surat. An ISO 9001 – 2008 Company manufacture of Cardiovascular Device specially diagnostic Angiography and Angioplasty material including coronary stent, Drug coated stent and Working on New Innovation of vascular devices like Retrieval device, Perfusion catheter, Distal protection device, Thrombolytic catheter, Bioabsorbable stent etc. They have Indian FDA approvals and will also receive CE certificate very shortly. They have dedicated infrastructure and research development facility and and trained staff.

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Mr. Vipul Sheth
(Managing Director,
Matrix Meditec Pvt. Ltd., Ahmedabad)

Mr. Vipul Sheth is Managing Director of Matrix Meditec (P) Ltd. – the company engaged in manufacturing and exporting of orthopaedic implants and instruments. He is also heading company named Life Sight Surgicals (P) Ltd - a company engaged in manufacturing and trading of Ophthalmic Instruments and intra ocular lenses. He has significant contribution in bringing and educating phaco emulsification technique in India.

He is a distinguished personality in the field of medical devices & instrumentation having experience of more than 20 years. He has been representing CARL ZEISS, Germany for more than a decade. He has also attended numerous workshops / seminars organized by SYNTHS, ZEISS in Davos, Switzerland, USA Germany. Mr Sheth is a science graduate and his company Matrix Meditec is actively involved in bringing new / unique technologies in the field of orthopaedic implants and instruments.

Dr S Mukherjee is Head - FCIPT Division, and Associate Dean - Academics of Institute for Plasma Research. He has 115 peer reviewed journal papers, 13 patents, guided 13 PhD scholars, and has contributed towards transferring FCIPT’s knowhow in industrial plasma applications for benefit of society. He is the 1st recipient of “BUTI Foundation Award” for outstanding contribution in plasma sciences and is a fellow of the Alexander von Humboldt foundation. He received the VASVIK-2016 award in the field of “Materials and Metallurgical Science and Technology” and was elected Fellow of Gujarat Science Academy in 2016.

His areas of research are industrial plasma applications, plasma applications in biology and developing plasma technologies for societal benefit.

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Mr. Prakash Bachani
Scientist E & Head (MHD)
Bureau of India Standard, New Delhi

Mr Prakash Bachani is MIE (Electrical Engg.) GOLD MEDALIST, Institution of Engineers, India. He is presently posted as Scientist E & Head (MUBO-1), Mumbai in Bureau of Indian Standards, for Certification Marks Deptt. In Mumbai at national level.

He has 32 years experience in Bureau of Indian Standards. At the Technical level, he has overseen the following activities:1. Product Certification, 2. System Certification (QMS), 3. Hallmarking of Gold and Silver, 4. Standards Formulation (Electrotechnical), 5. Laboratory Management.

In conformity assessment of the products in electrotechnical area, includes cables; conductors; energy meters; electrical accessories like switch, plugs and sockets, MCBs; electrical appliances like geysers, fans, motors, pumps, ballasts; GLS Sodium and compact fluorescent lamps; luminaries etc.

He has participated and presented several papers relating to Standardization, Certification in the field of Electrical Engg. at various seminars organized in the
country. He has also participated in the meetings of IEC for Rotating Machinery in China, Power Capacitors in Russia and Transformers in Japan.

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Dr. Chirag Patel
Assistant Professor, Microbiology
Shree Krishna Hospital, Karamsad

He is practising since 10 years as Infection preventionist, Clinical Microbiologist, academician and guide for MBBS and MD students in medical college.

He has published 6 international and national level research papers and has 7 international and national level papers under acceptance.

He has completed 9 Research projects and is currently working on 8 other projects.

His Primary areas of interest are: Indwelling medical device associated infections, Multi-drug resistant organism in healthcare associated infections, Microbial diversity in Blood stream infection and Respiratory tract infections.

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Mr. Hiten Bheda
Managing Director
Vinit Performance Polymers Pvt Ltd., Mumbai

Mr. Hiten Bheda , a Chemical Engineer by training has been associated with plastics since the beginning of his career. He pursued a BS degree in Chemical Engineering from the University of Tennessee, Department of Chemical and Polymer Engineering, Knoxville, USA where his interest in Polymer processing was nurtured.

He did his Masters in Chemical engineering from the University of Connecticut. During those years he was fortunate to learn about polymer processing and train under some of the renowned professors of Rheology.

He was associated in conversion of Engineering Plastics and have worked on Casting of Polyamides, Polyurethanes as well as extrusion of EP and High Performance Polymers. He has closely worked with many OEM’s and Govt institutions for successful application of these products involving extensive design and testing of materials for qualification.

Currently he is Managing Director of Vinit Performance Polymers Pvt Ltd., engaged in conversion and CNC machining of engineering plastics and high performance plastics under POLYMAT brand. The company pioneered extrusion of high temp materials like PEEK in India.

He has served the trade in the capacity of Hon Secretary AIPMA, Hon editor of Plastic News, and currently is Vice President West Zone AIPMA. He has represented AIPMA for Govt advocacy on fiscal matters like budget and GST. Active member of SPE, he is keen to further cause of plastic processing through knowledge enhancement.

He is member of Tau Beta Pi, a honorary engineering fraternity based in the USA.

He spends his free time to support social causes through family trust providing medical help and vocational training in suburb of Mumbai, is associated with education trust BNKCT as Managing Trustee.