Smarter CER Maintenance: Achieving Efficiency, Consistency, and ROI with AI

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Overview What You Will Learn Webinar Speakers

Overview

Smarter CER Maintenance: Achieving Efficiency, Consistency, and ROI with AI

Where

Online Webinar

When

10 AM ET

Overview

Maintaining Clinical Evaluation Reports (CERs) has become one of the most resource-intensive challenges for medical devices and IVD manufacturers operating under EU MDR and IVDR. As portfolios grow and renewal cycles tighten, organizations are expected to demonstrate continuous clinical evidence maintenance, not just point-in-time CER updates.

Manual CER maintenance – periodic literature refreshes, version comparisons, and portfolio alignment often strains regulatory and clinical teams. These repetitive, time-consuming activities divert subject matter experts away from higher-value scientific analysis, risk assessment, and regulatory strategy.

In this upcoming Celegence webinar, our experts will demonstrate how AI-driven automation transforms CER maintenance from a reactive obligation into a scalable, sustainable process.

Attendees will see how CAPTIS®, Celegence’s AI-powered regulatory compliance platform, supports automated literature surveillance, structured version comparisons, and portfolio-wide consistency—enabling faster updates while strengthening audit readiness and regulatory confidence.

Who Should Attend

This webinar is designed for professionals responsible for clinical evidence generation and maintenance, including:

Regulatory and Clinical Affairs professionals managing EU MDR and IVDR compliance
Medical writers and CER reviewers supporting ongoing updates
PMS, PMCF, and Quality teams integrating post-market evidence into CERs
Organizations overseeing multiple medical devices or IVDs across portfolios

Why Attend

This webinar offers a practical, forward-looking view of how AI-enabled automation supports sustainable CER maintenance, reduces operational burden, and strengthens regulatory readiness especially for organizations managing large and evolving portfolios.

Join us to gain clarity on how CER maintenance can support innovation rather than constrain it.

What You Will Learn

During this session, our speakers will cover:

Moving from periodic, manual CER updates to a continuous maintenance model aligned with EU MDR and IVDR expectations
Reducing manual workload while preserving scientific rigor, traceability, and documentation quality
Managing CER updates efficiently across large and complex devices and IVD portfolios
Supporting audit readiness through standardized structures, consistent updates, and transparent evidence tracking
Practical use cases demonstrating how AI and automation support day-to-day CER maintenance activities

Webinar Speakers

Senior Manager – Medical Device Services

Dr. Pratibha Mishra

Dr. Pratibha Mishra holds a master's degree in Oral Medicine and Maxillofacial Radiology and has previously worked as a clinician and lecturer. She specializes in the clinical evaluation of simple-to-complex medical devices, including combination products and medical device software. She has authored and reviewed regulatory templates and clinical evaluation documentation across a wide range of therapeutic areas and provides strategic guidance on clinical evaluation, post-market surveillance, post-market clinical follow-up, and clinical evidence pathways. Under her leadership, teams have successfully addressed Notified Body observations from BSI, TÜV SÜD, Intertek, GMED, and DEKRA on the path to CE marking under EU MDR.

Associate Manager – Medical Device Services

Rohan Sathe

Rohan Sathe brings over nine years of experience in the medical device and clinical trial industry, with deep expertise in developing and reviewing Clinical Evaluation Reports across multiple device classes and therapeutic areas. He has extensive experience in Software as a Medical Device (SaMD), biostatistics, PMS, and PMCF, and has led multiple client engagements addressing Notified Body observations. Rohan works closely with regulatory affairs, clinical affairs, and quality teams to support compliant, efficient, and sustainable CER maintenance strategies.