Highly skilled regulatory affairs professional Aaditya brings over 15 years of progressive experience in the healthcare industry. With a focus on ensuring compliance with regulatory requirements for medical devices and healthcare products, Aaditya has led regulatory strategies, managed deliverables, and ensured organizational compliance.

His expertise spans clinical trials, medical writing, Electronic Data Capture (EDC), Medical Devices, and IRB. Having worked at Johnson & Johnson and Abbott Rapid Diagnostics, Aaditya possesses a proven track record in the industry.

Aaditya is a key opinion leader actively engaged with industry associations like MTaI, APACMed, FICCI, and AMCHAM. As Vice-chair of India RA COE for APACMed and MTaI, he significantly contributes to the regulatory landscape, showcasing his thought leadership by authoring regulatory white papers on topics such as digital health, SAMD and Medical Device Standards etc.

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Anil Srivastava, a distinguished leader in healthcare business management with over three decades of unparalleled expertise. Currently serving as the Chief Operating Officer for Nihon Kohden India, Anil has built an impressive career across prestigious global corporations, including Philips, SonoSite Inc., Medison (now part of Samsung), as well as HCL Picker.

Anil is renowned for his excellence in medical equipment and in vitro diagnostics, with a solid track record of establishing strong brands and leading cross-functional teams. His ability to cultivate enduring client relationships and drive business growth is a testament to his dynamic leadership style. Passionate about technology, Anil possesses a unique ability to adapt swiftly to emerging trends, steering organizations toward innovative solutions in the healthcare landscape.

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Bivash CHAKRABORTY - Head – Regulatory Affairs , Quality & Government Affairs – South Asia , working for bioMerieux India Pvt. Ltd for last 25 years. Associated with IVD industry for over 30 + years in various cross functional areas. An active Industry member representing various working group on IVD& Medical devices (Co Chair – IVD Subgroup with CII & FICCI). Post Graduate Diploma in Regulatory Affairs & Lead Auditor for ISO 9001:2015, 13485:2016 & CII Lean Six Sigma Green Belt

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Expert in Medical Devices | Clinical Research Specialist | Distinguished Speaker

Dr. Ashish Indani is a distinguished expert in medical devices, clinical research, and regulatory sciences, with over 25 years of experience shaping advancements in healthcare and life sciences. As a qualified physician with an MBA in Clinical Trial Management, he has contributed extensively to the fields of medical technology, translational research, and digital health solutions.

Dr. Indani has authored over 200 publications and holds more than 20 patents, reflecting his commitment to innovation and scientific progress. His expertise extends to artificial intelligence, blockchain, quantum computing, robotics, augmented reality, and their applications within medical technology. He has been an expert speaker at more than 200 international conferences, engaging with professionals and academics on critical advancements in healthcare.

His ability to present complex scientific developments in an accessible and insightful manner has established him as a respected voice at leading forums, including TEDx and industry summits. His contributions to regulatory sciences, clinical methodologies, and emerging healthcare technologies continue to influence policy and practice worldwide.

Areas of Expertise

• Medical Device Clinical Research: Regulatory frameworks and innovative methodologies
• AI & Blockchain in Healthcare: Exploring advancements in digital health integration
• Translational Research: Bridging scientific discoveries with practical applications

Selected Publications

• Essentials of Medical Device Clinical Research – An authoritative guide on clinical research in the medical device industry
• 50 Things That Cause Obesity – A critical exploration of obesity-related factors
• Mud Therapy: Healing Through One of the Five Elements – An examination of alternative medicine and therapeutic practices
• Defeat Headache – Insights into headache management and prevention

Awards & Recognitions

• Black Buck Award – Recognized for contributions to medical sciences
• State Award – Honored for excellence in healthcare research
• President’s Scout Award – A distinction for leadership and contributions

Dr. Indani's dedication to scientific advancement, medical innovation, and knowledge dissemination continues to shape industry standards and the future of healthcare.

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Dr Rajiv Chhibber, PhD – Vice President External Affairs, Sahajanand Medical Technologies Ltd

Dr Rajiv Chhibber is a Senior Corporate Affairs, Policy, Communications & Media Strategist with two decades of experience across several industries including Pharmaceuticals/Medical Devices and has worked in the past in the Development Sector in the key areas of Healthcare, Climate Change, Energy and Sustainable Development.

Dr Chhibber is currently Vice President, External Affairs at Sahajanand Medical Technologies, a leading developer and manufacturer of minimally invasive coronary and vascular systems.

As a seasoned Public Policy Strategist and a speaker at global symposia’s like WHO, World Economic Forum, G20, QUAD Alliance, ASEAN etc, Dr Chhibber has been a key intermediary to shape global health diplomacy & strategy that has driven sectoral growth through innovative initiatives & collaboration with diverse stakeholders, including large networks across US, Asia, Africa, Europe and Latin America, encompassing governments, civil society, communities, businesses, donors, & UN/multilaterals, agencies. He has the distinction of being the 1st MedTech lead to represent the Indian Medical Device Industry at the World Economic Forum, Davos in Jan 2024. Dr. Chhibber is a member to various government/industry and academic bodies & committees in areas of public health advocacy, Pharma, Medical Devices, Environmental health and climate change where he plays a stewardship role in assisting the governments vision to achieve the SDGs and advancing Health systems. He provides mentorship to numerous academic institutions in the areas of MedTech, HealthTech, Public Health & Sustainability, driving the ‘Industry-Academia’ approach.

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A dynamic healthcare policy expert and industry leader with extensive experience across healthcare, diagnostics, wellness, pharmaceuticals, and medical devices. Currently serving as Advisor – Health at the PHD Chamber of Commerce and Industry, he plays a key role in national healthcare policy advocacy. He also serves as Technical Officer and Joint Coordinator for Government Affairs and Policy at AiMeD, India’s largest medical device industry association. His affiliations span across prestigious bodies, including the Bureau of Indian Standards, Delhi Pharmaceutical Science & Research University, Medical Cobotics Centre at IIT Delhi, and international platforms like the Global Advisory Board of the International Patient’s Union. He has also contributed to national missions under the Ministry of Electronics and Information Technology and NPE 2024.

He is credited with several high-impact initiatives, including the ban on refurbished medical equipment imports, reduction of customs duties on key diagnostic components, and launching India’s first digital hospital and Smart Tele-Clinics in Gujarat. He played a key role during the COVID-19 crisis by launching e-marketplaces, Tele-ICU centres, and mass vaccination drives. His innovations include devices in digital healthcare and research on diabetic neuropathy. Widely recognized for his contributions, he has received multiple awards such as “40 under 40 Healthcare Leaders,” the Healthcare Icon Award, and the Acharya Chanakya Shikshavid Samman. His work reflects a strong commitment to healthcare innovation, accessibility, and impactful policy reform.

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Dr Muthu is the Vice President – Quality & Regulatory Compliance at Tricog, a global healthtech innovator specializing in AI-driven cardiac care solutions. With over 20 years of experience in the medical device and digital health industries, he is a recognized expert in global regulatory strategy, quality systems, and compliance for AI/ML-based medical technologies and Software as a Medical Device (SaMD).

At Tricog, Muthu leads end-to-end quality and regulatory functions across multiple geographies, including the US, EU, and India. He has successfully overseen numerous global regulatory submissions, ensuring seamless market access while supporting innovation through compliance. He is a frequent speaker and contributor at industry forums and brings a pragmatic, solutions-driven approach to the evolving MedTech landscape.

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Goutam Bhattacharya is a Life Sciences professional with more than three decades of working experience in leading multinational pharmaceutical and medical device companies in India. Prior to joining Council, he has worked in senior leadership positions with companies in India like LG Life Sciences; Boston Scientific, Win-Medicare, Plethico Pharma, having started his career with Lupin Labs.

Goutam is a Bachelor of Science & MBA (Marketing). He has acquired deep domain knowledge in pharmaceuticals, biologics, medical devices, diagnostics, vaccines & agrochemicals sectors. He brings with him hands-on working experience in managing multi-disciplinary teams involved in business development & licensing of assets; CRAMS; co-marketing/ promotion; product sourcing; regulatory affairs; clinical trials and sales & marketing. He has been instrumental in successfully identifying & licensing-in of highly differentiated products from US, EU, Japan, Korea, Canada etc. in his past assignments.

Goutam joined LSSSDC in 2023 and has been extremely passionate about adding value to Life Sciences sector through skilling, capacity building and entrepreneurship. He has been collaborating with multiple stakeholders from across life sciences ecosystem like Government; Academia; Life Sciences Industry & associations and partners to successfully deliver the mandate of providing skilled manpower to the Life Sciences sector.

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Mr Himanshu Baid is the Managing Director of Poly Medicure Limited (Polymed). He holds a Bachelor's degree in Electronics and Communication Engineering.

Mr Baid embarked on a journey to revolutionize the healthcare industry & founded Polymed in 1995, leveraging his profound understanding of MedTech and market dynamics. In his role as Managing Director, Himanshu oversees Polymed's global sales, operations, and growth strategies. Under his leadership, the company has consistently delivered sustainable growth and operational excellence. His vision is rooted in providing innovative, safe, and quality healthcare solutions, contributing to a healthier world. He was honoured with the prestigious Ernst & Young Entrepreneur of the Year Award in the Healthcare & Life Sciences category for 2024. He holds key positions in various industry bodies, notably as the Vice President, NATHEALTH and Chair, Medical Device Committee at PHD Chambers.

Mr Himanshu Baid also serves as the Chairman of Exicom Tele-Systems, which specializes in electric vehicle supply equipment solutions (EV Chargers) and critical power solutions.

His leadership and strategic vision have propelled Polymed to the forefront of the global healthcare industry, embodying a commitment to quality, innovation, and societal impact.

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Jhankhana Gyani is working with Draeger India as Vice president – Quality & EHS, Heading the Quality and Regulatory function of the organization . She is also heading the Sustainability and employee health & Safety function in Draeger India

Draeger is one of the world leaders in manufacturing critical Medical devices and safety equipments

Jhankhana is electrical engineer by qualification and has Masters in Business Management

Lead auditor for ISO 13485, ISO 9001, ISO 14001 and ISO 45001.

She has more than 30 years of work experience in various areas and varied industries.

She started her career as R&D engineer in Siemens Medical dealing with diagnostic devices to gradually move towards product and process quality. She has worked with Patni Computers as senior Quality manager handling software project management, competency management & Improvement initiatives. She also has experience as management consultant, Lead Quality Auditor and trainer for several organizations including Tata power.

Last 11 years She is leading Quality and Regulatory team at Draeger India.

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He currently serves as a Scientist at the Bureau of Indian Standards (BIS) in the Medical Equipment and Hospital Planning Department. His role involves contributing to standard formulation in the fields of medical biotechnology, nanotechnology, and medical devices—particularly those used in ENT specialties.

He a Biomedical Engineer with a keen interest in applications of Nano Biophotonics. He has worked on the development of transdermal patches for drug delivery and conducted tribological analysis of hip implants, utilizing nanostructures to reduce wear, enhance implant longevity, and to ensure effective lubrication

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Malte Knowles Schmidt has been working in various roles in the healthcare and medical device industry. Here he worked as a Product Leader with a broad portfolio of devices and applications, from pacemakers and medical imaging technology, to user centered software solutions helping women with gestational diabetes. In his role as Global Portfolio Manager for Software as Medical Device, AI and Cybersecurity at TÜV SÜD Medical Health Services, he is focused on solving real customer problems and providing solutions that enable market access.

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Nitin Gupta, Managing Director of FUJIFILM Sonosite India & South Asia, boasts 28+ years of adeptness in the Medical Devices sector. Nitin's expertise spans P&L Management, Sales, Channel, and Product Management, coupled with a knack for New Product Introductions and Service Marketing. His forte lies in adeptly leading cross-functional teams, and consistently propelling growth. With a robust history at GE Healthcare, he excelled in business development, strategizing, and aligning operations with organizational objectives.

Nitin holds an MBA in Marketing from Sikkim Manipal Institute of Technology and a Bachelor's in Electronics Engineering from Lucknow University, underscoring his multifaceted skill set and astute leadership.

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Postgraduate in Pharmacy, with over 13 years of Regulatory Affairs experience in Pharmaceutical, FMCG, and Medical Device profile. Currently he is handling role of Senior Director, Quality and Regulatory Affair, Asia Pacific, Fresenius Medical Care.

Prior to this role, he has served as Head- of Regulatory Affairs, Quality, and Government Affairs at Fresenius Medical Care (India). Before joining Fresenius, he was holding different positions in Eli Lilly and Reckitt Benckiser. He proudly holds different honorary government and Industry trade positions. He is an Expert Member, Biological & rDNA Committee- Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Co-Chair- NatHealth, Chair-India Regulatory Affairs in APACMed, and Chair- ISCR.

He is also RAPS Board Certified Regulatory Affairs Professional in Global Medical Devices.

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Preety Sharma is currently working as Head – Regulatory Affairs at Edwards Lifesciences. With ~14 years of professional experiences in Regulatory Affairs and Quality Assurance, she is leading regulatory affairs team of Edwards lifesciences for Indian sub-continent. An active Industry member contributing in various working group on Regulatory Affairs in MTAI, FICCI, AdvaMed, & AMCHAM. Graduate and post graduate in Biotechnology and Post graduate diploma holder in regulatory affairs. She is trained on ISO 14971, MDSAP & EUMDR. She is certified Six Sigma Green belt holder, ISO 13485 Lead auditor and RAC – Devices certification holder. She has worked for organizations like Boston Scientific, CDSCO and Morepen Labs Ltd

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A prominent leader in India’s medical device sector, currently serving as the President of the All India Syringes & Needles Manufacturers Association (AISNMA) and the Founder/Coordinator of the Association of Indian Medical Device Industry (AiMeD), an umbrella organization representing over 400 Indian manufacturers of medical devices, including consumables, disposables, equipment, instruments, implants, electronics, and diagnostics. He also serves as a Board Member of the Kalam Institute of Healthcare Technology and is a Member of the National Medical Device Promotion Council. Actively engaged in shaping policy and regulatory frameworks, he chairs the Technical Committee for ICMED Certification under the Quality Council of India (QCI) and is a Member of the Expert Advisory Group for Biomedical Device and Technology Development (BDTD) under the Department of Science & Technology. Additionally, he is a Member of the Medical Devices Expert Advisory Group to the Central Drugs Standard Control Organization (CDSCO) and serves on the Steering Committee of the National Biodesign Program. His work reflects a deep commitment to advancing indigenous innovation, regulatory reform, and self-reliance in India’s medical device ecosystem.

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Sailesh is an Enthusiastic Leader in Regulatory Affairs, hands on with Life Cycle Management of Biologics, Sterile & Oral Drugs in Emerging Markets, EU and CE Marked Medical Devices & Combination Products. Pharmacist by education with Masters in Pharmaceutical Technology, PG Diplomas in Business Management, Drug Regulatory Affairs & Patents Law.

Experienced in designing Strategies for New Product Introduction, Life Cycle Management and Handling Regulatory & Notified Body Audits.

Passionate about Leadership, People Management, Change Management in the field of CMC and Medical Devices Regulatory Affairs.

Designing Regulatory Strategy, mentoring, coaching and leading team towards a common business goal keeps him motivated

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Somesh Rasal is a seasoned cybersecurity Professional with over a decade of experience safeguarding critical systems in the healthcare and other technology space. Currently serving as the Global Service Line Manager for Cybersecurity in the Medical Health Division of TÜV SÜD, Somesh leads a specialized team dedicated to cybersecurity testing and securing medical device equipment across global markets. With a strong foundation in cybersecurity principles and a deep understanding of medical technologies, Somesh has played a pivotal role in ensuring compliance, patient safety, and data integrity in an increasingly connected healthcare ecosystem. His leadership is marked by a commitment to innovation, risk management, and cross-functional collaboration. Somesh is passionate about advancing cybersecurity standards in the medical field and continues to drive initiatives that enhance resilience and trust in healthcare systems worldwide.

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Sreejith is currently the Director- RAQA for Stryker Global Technology Centre, India. He has held several senior management roles over his career of more than 2 and a half decades in medical device domain in Stryker, GE Healthcare and BPL Healthcare in areas of process engineering, product quality, quality assurance and regulatory affairs. He has been in multiple FDA Inspections, led the site for multiple MDSAP audits and various other inspections and audits for medical devices. A veteran in medical device Quality and Regulatory domain who is passionate to make healthcare better, safer and accessible. He has led teams to release and register a number of products across global markets and also a Lead auditor for ISO 13485:2016 and ISO 9001: 2015. He also is part of different industry associations like APACMED and is also involved in policy advocacy across region.

Exp: 25 Years of Total Experience, 24 years in Medical Device domain.

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With 15 years of experience, Mr. Sundeep Agarwal’s leadership serves as a guiding light for both regulatory bodies and industry professionals. He has delivered several global webinars and training sessions. A luminary within the MedTech and Life Sciences domain, boasts a multifaceted portfolio as a distinguished global speaker, adept trainer, and seasoned consultant specializing in Regulatory Affairs, Quality Assurance, Quality Management Systems (QMS), Software as a Medical Device (SaMD), Artificial Intelligence (AI), Software Validation, IT and Cybersecurity, FDA and CE approvals, Good Manufacturing Practice (GMP), and Industrial manufacturing.

He is currently serving as the Senior Vice President, Regulatory Affairs & Quality Assurance at Remidio, a pioneering entity renowned for its SaMD and AI devices in Ophthalmology in India, Singapore, and United States. His affiliations extend to being an active member of a technical committee (Work Group - Software as Medical Device) at Global Harmonization Working Party. Additionally, his contributions to education, as a distinguished guest lecturer in various Management, Pharmacy and Engineering institutions in India, Germany, Singapore, underscore his commitment to continuous learning and academic excellence. Academically, he holds a Master of Technology, an MBA, and a Post Graduate Diploma in Medical Law, underscoring his commitment to continuous learning and scholarly pursuits.

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Global Regulatory Affairs Leader | Medical Device Expert | Policy Contributor

Ms. Sushmita Roy Chowdhury is a highly accomplished and result-driven regulatory specialist with over 23 years of experience in the medical device industry. She has held leadership positions with global medtech giants including B. Braun, Roche Molecular, and Baxter, and contributed strategically at national platforms such as Andhra Pradesh MedTech Zone (AMTZ)—where she also established and continues to serve as Member Secretary of the Ethics Committee.

Renowned for her expertise in global regulatory compliance, quality systems, and international market access, Ms. Sushmita is a leading voice in India’s growing medical technology sector. She holds a Postgraduate Diploma in Pharmaceutical Regulatory Affairs (PGDPRA), a Master’s in Foreign Trade, and is a certified ISO 13485 Lead Auditor.

Her regulatory influence includes collaboration with WHO principals, and a pivotal role in the drafting of India’s Medical Device Rules, 2017 (MDR 2017)—a cornerstone regulation now followed by domestic and global manufacturers, importers, and exporters.

As a recognized policy advocate and thought leader, Ms. Sushmita has contributed to India’s visionary "Vision 2047", and has worked closely with institutions like ICMR and NITI Aayog on strategic national initiatives. She actively promotes awareness on Materio-vigilance in collaboration with the Indian Pharmacopoeia Commission (IPC), and is a strong proponent for the inclusion of biomedical engineers in regulatory and manufacturing ecosystems.

A strategic thinker and regulatory trailblazer, Ms. Sushmita Roy Chowdhury continues to empower medical device companies to achieve timely, compliant, and globally competitive product launches.

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• 25 years of industry experience, 20 years in the Healthcare domain.
• Currently Senior Manager, Quality Assurance, Digital Solutions at GEHC. Was SeniorManager, QMS for all India sites accounting for 3000+ employees. Responsible for QMS deployment, Quality Management Reviews and audit management.
• 20 years with GE HealthCare- rich experience across Design Engineering andManufacturing. End-to-end product development experience through all phases of product conceptualization, design, manufacturing, product sustenance and end-of-life.
• Expert in Cybersecurity, Privacy, Regulation of Artificial Intelligence, Software Development Lifecycle, Computer System Validation and Risk Management.
• Hands-on experience with Interventional Cardiology, Anesthesia, Ultrasound, CT, Xray and Digital solutions. Part of core team for several flagship products and solutions.
• Experience with several regulations, including India (CDSCO & BIS), USA (21 CFR), Brazil (Anvisa), Tanzania, Kenya, Australia, Canada, EU MDD & MDR.
• Participation in review of ISO draft standards and guidances.
• Masters in Business Laws from NLSIU, Bachelors in Engineering from Bangalore University.
• 2 patents
• BIS certified Lead Auditor- 13485. Rich exposure to regulatory audits.

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