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D2.S7: Risk Management for Medical devices
Session Chair(s)
Ashish Indani
Managing Director, Krishnamugdha Advance ResearchTeck, India
Session Overview: Risk Management is the most critical function in medical device lifecycle management. While there are several set guidelines in Medical Devices including ISO 14971, the width of diversity of devices compels use high level of discretionary efforts, deliberation and carefully individualized approach for each device. This requires critical intersecting expertise in Medical Devices, understanding of clinical use and human factors, thorough knowledge of Risk Management, and systematic approach of evidence-based compliances.
Speaker(s)
Sushmita Roy Chowdhury
General Manager - Regulatory Affairs, Romsons Group Pvt Ltd, India
Managing Risks or Risk Management? - A holistic approach to ensure that device risks are realistic and not realized
Kalindi Hapani
Senior Manager, Medical Safety & Device Safety, COD Research, India
Risk Communication: Pathway from Risk management to Labelling
Preety Sharma
Head - Regulatory Affairs, Edwards Lifesciences, India
Panel Discussion: Accelerating Innovation While Managing Risk: Global Regulatory Trends in MedTech
Manoj Karwa
Head of Clinical Trials & Pharmacovigilance, Auriga Research, India
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