Optimizing CER and PMS Document Writing with Technology and AI – Webinar with Medtech Intelligence

Product Specialist, Regulatory Services, Celegence

Shruti Sharma

Shruti Sharma is an accomplished Product Specialist for CAPTIS™, leveraging a strong background in Medical Writing. With over 7 years of expertise in Medical Device Regulatory Affairs, Shruti excels in Clinical Evaluations for Medical Devices across diverse therapeutic areas. Her proficiency extends to crafting essential regulatory documents, including CEPs and CERs, PMSRs, and SSCP, along with MDR compliant comprehensive CEP and CER templates for medical device manufacturers, tailored to the requirements of their product portfolio. She brings this unique blend of experience to the role of moderator for the webinar, seamlessly connecting Medical Writing and Technology for insightful discussions.

Manager, Medical Device Services, Celegence

Dr. Pratibha Mishra

Pratibha has a master’s degree in Oral Medicine and Maxillofacial Radiology and has previously worked as a clinician and lecturer. Authored and reviewed templates and regulatory documentation for medical devices covering a wide range of therapeutic areas including dentistry, cosmetic surgery, diagnostic imaging, interventional radiology, general and electrosurgery, and many more. Provides strategic advice to Celegence clients on regulatory strategy for clinical evaluation, PMS including PMCF, and Clinical Evidence pathways. Leads a team of qualified medical writers. Successfully completed several projects related to addressing Notified Body observations on the road to CE Marking of medical devices under EU MDR.