Sessions
Leveraging Post-Market Clinical Follow-Up (PMCF) Data for Monitoring Safety and Performance of your Medical Device
12:45 PM - 2:45 PM Mon
Optimizing Medical Device Life Cycle Management: Navigating Regulatory Pitfalls and Enhancing Compliance Across Global Markets
9:20 AM - 9:55 AM Wed
Dr Pratibha Mishra
Manager/Sr. SME, Medical Device Services, Celegence
• Pratibha Mishra has a master’s degree in Oral Medicine and Maxillofacial Radiology and previously worked as a clinician and lecturer.
• She has written and reviewed templates and regulatory documentation for medical devices covering a wide range of therapeutic areas – dentistry including implantology, ophthalmology, cosmetic surgery, diagnostic imaging, interventional radiology, gastroenterology, female reproductive health, nephrology, and dialysis, general and electrosurgery, thoraco-pulmonology, cardiology, diabetes, wound care, musculoskeletal disorders, instrument reprocessing and care.
• At Celegence, she provides strategic advice to customers on regulatory strategy for clinical evaluation, Post-Market Surveillance including Post-Market Clinical Follow-up, and Clinical Evidence pathways. She leads a team of qualified medical writers, expert in clinical evaluation of simple-to-complex medical devices, including Medical Device Software. Her team has successfully completed several projects related to addressing Notified Body observations (BSI, TÜV SÜD, Intertek, GMED, and DEKRA) on the road to CE Marking of medical devices under EU MDR.