6th Annual Medical Device
Regulatory and Quality
India is among the top 20 markets for medical devices worldwide. India's medical devices market stood at US$ 11 billion in 2020 and is expected to reach US$ 65 billion in 2024. The Government of India (GOI) has commenced various initiatives to strengthen the medical devices sector, with emphasis on research and development (R&D) and 100% FDI for medical devices to boost the market. From April 2000 to March 2021, FDI inflow in the medical and surgical appliances sector stood at US$ 2.19 billion. By 2025, the Indian market for medical equipment is predicted to increase from US$ 11 billion to ~US$ 50 billion. The Indian medical devices sector is estimated to be worth ~US$ 10 billion in 2021.
The 6th Annual Medical Device Regulatory and Quality Summit 2022 will create a platform for regulators, industry stalwarts to come under one roof to discuss and share ideas that would not only benefit their organisations, but at large the industry as well. The conference will review the evolving regulations, their impact on the industry as well as take an in depth look into areas of quality control and assurance.
Certification and Regulatory Affairs Russia & EAEU Elmas-Medical
Alok Kumar Soni
Head Regulatory Affairs & Quality Assurance - India & South Asia
Bio-Rad Laboratories (India) Pvt. Ltd.
Head – Regulatory Affairs & Quality & Public Business – India & South Asia
Biomerieux India Pvt. Ltd.
Dr. Ashish Indani
Senior Manager Clinical Affairs
Stryker Global Technology Center
Dr. Ashok Thakkar
Head - Clinical Research
Meril Life Sciences Pvt. Ltd.
Dr. Giridhar J. Gyani
Association of Healthcare Providers - AHPI India
Hari Babu Sudharsanam
Research Scientist I - Biocompatibility Lead Preclinical QA India
Baxter Innovations and Business Solutions Private Limited
Senior Manager-Quality and Regulatory Affairs
Beckman Coulter India Pvt. Ltd.
Associate Director - Regulatory Affairs
Abbott Healthcare Pvt. Ltd.
Madhusudhan D H
Site Quality leader, RCS Quality
Medtronic India Development Centre
Mamatha S G
Executive Global Quality Systems & Total Quality India Leader India Sites, GEHC-SA I&D Leader
Head - Regulatory Affairs, Quality and Government Affairs
Fresenius Medical Care (India) Pvt. Ltd.
Head - Regulatory Affairs
Boston Scientific India Pvt. Ltd.
Head - Regulatory Affairs
P V Mathew
Sc-E and Head (MHD)
Bureau of Indian Standards
Hindustan Syringes & Medical Devices Ltd.
Founder and Forum Coordinator
Association of Indian Medical Device Industry (AiMeD)
Director Regulatory Affairs & Quality Assurance
Terumo India Pvt. Ltd.
B.E. (Chem), Dip Packaging Technology
Poly Med Analytical Pvt Ltd
Director - Regulatory & Government Affairs
Philips India Ltd.
Director- Government Affairs
DHR Holding India Pvt ltd.
General Manager - Compliance & Regulatory Affairs
Director, Development Monitoring & Evaluation Office
Deputy Director |NABCB National Accreditation Board for Certification Bodies
Quality Council of India
Director-Health Economics & Govt Affairs, India HUB & ASEAN
- The Impact of MDRs and the way forward for Medical Devices in India
- MDR overview - Main regulation changes, challenges you will meet during transition and strategies for their overcome
- Quality management in view of new regulations and patient safety
- Clinical Evaluation and Investigation for Devices
- Strategies related to MDR certification
WHY SHOULD YOU ATTEND
- Get familiar with new regulatory and compliance changes
- Take part in our industry discussion about evolving regulatory and quality management
- Be up-to-date with the latest in the Medical Device Industry
- Gain insight into the upcoming regulatory changes and quality management
- Discuss the advantages and disadvantages of recent Industry changes
- Understand detailed and lates regulatory updates on Medical Devices and IVDs
- Benefits of a Harmonized Quality Management System
- Insights on regulatory training, standards, and guidance
- Ensuring Compliance, Quality and Patient Safety
- Exploring Artificial Intelligence in medical device
- Managing labelling requirements and ensure you remain compliant to changing expectations
- Deep dive sessions on compliance and strategic priorities
- Leverage on this golden opportunity to meet and connect with regulatory bodies and industry experts
WHO WILL YOU MEET?
- Government Authorities
- Medical Device manufacturers
- Medical Device distributors
- Registration and regulatory consultants
- Medical Device packaging companies
From Which Departments?
- Legal & Regulatory Affairs
- Government Affairs
- Product Regulations
- Quality Control & Assurance
- Research & Development
- New Product Development
- Packaging and Labelling