Sponsored by:

Complimentary Webinar Recording
|Recorded on September 26, 2023|

Optimizing CER and PMS Document Writing with Technology and AI


This session will delve into common non-conformities encountered during clinical evaluations and explore how technology can play a pivotal role in resolving these challenges. We will also discuss practical process adjustments made to prevent the recurrence of these non-conformities in subsequent reviews. Gain insights into the practical application of technology to address regulatory hurdles and improve submission outcomes.


  • To develop a clear understanding of the specific criteria and key aspects that notified bodies prioritize during their review of Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and Clinical Development Plans (CDPs)

  • Practical strategies and tips to enhance efficiency when managing regulatory documentation.

  • Gain insights into viewing technology as a powerful tool for long-lasting compliance and ease of maintenance. As well as learn to see technology adoption not just as a short-term solution, but as a strategic investment that pays off in sustainable regulatory compliance and streamlined maintenance processes.


  • Medical Device Manufacturers
  • Top management / VPs
  • R&D managers
  • Regulatory Affairs Professionals
  • Quality Assurance Professionals
  • Medical Device Executives
  • Technical Writers and Managers
  • Medical Writers / Reviewers
  • Medical Device Executives
  • Clinical Managers


Dr. Pratibha Mishra

Pratibha Mishra
Manager, Medical Device Services

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.


Shruti Sharma
Product Specialist, Regulatory Services

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.

Share This