Dr. Pratibha Mishra

Dr. Pratibha has a Master’s degree in Oral Medicine and Maxillofacial Radiology and has previously worked as a clinician and lecturer. She specializes in clinical evaluation of simple-to-complex medical devices, including combination products, and medical device software. She has authored and reviewed templates and regulatory documentation for medical devices covering a wide range of therapeutic areas.

In her role as subject matter expert, she provides strategic advice to customers on regulatory strategy for clinical evaluation, post market surveillance including post market follow-up, and clinical evidence pathways. She leads a team of qualified medical writers in clinical evaluation of simple-to-complex medical devices, including medical device software. Her team has successfully completed several projects related to addressing observations from Notified Bodies (BSI, TÜV SÜD, Intertek, GMED, and DEKRA) on the road to CE Marking of medical devices under EU MDR.