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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)
Managing Risks or Risk Management? - A holistic approach to ensure that device risks are realistic and not realized
Sushmita Roy Chowdhury
Romsons Group Pvt Ltd, India
General Manager - Regulatory Affairs
Risk Communication: Pathway from Risk management to Labelling
Kalindi Hapani
COD Research, India
Senior Manager, Medical Safety & Device Safety
Panel Discussion: Accelerating Innovation While Managing Risk: Global Regulatory Trends in MedTech
Preety Sharma
Edwards Lifesciences, India
Head - Regulatory Affairs
Manoj Karwa
Auriga Research, India
Head of Clinical Trials & Pharmacovigilance
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