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Overview What You Will Learn Webinar Speakers Who Should Watch?

With upcoming changes in regulatory expectations, Notified Bodies are placing stronger emphasis on scientific rigor, evidence defensibility, and traceability in Clinical Evaluation Reports (CERs) — not just check-the-box compliance. For medical device manufacturers, this means traditional CERs may no longer suffice.

This webinar helps you adapt your CER strategy to meet the 2026 standards. You’ll discover how to build audit-ready CERs, craft systematic literature reviews (SLRs) with clarity and traceability, and integrate documentation workflows that stand up to deeper scrutiny.

Where

Online Webinar

When

March 12, 2025 | 10:00 AM ET

What You Will Learn

Key Discussion Points

  • Clear guidance on endpoint justification and acceptance criteria — how to define and defend performance/safety endpoints, including handling zero-event data and setting credible confidence intervals
  • SLR design best practices — strategies to ensure your literature reviews are reproducible, relevant, and defensible
  • Traceability across documentation — linking claims, evidence, risk management, and post-market plans for seamless regulatory compliance
  • Workflow tips using digital tools and automation — to maintain efficiency while ensuring audit readiness
  • A “lean but resilient” CER roadmap for 2026 — balancing regulatory rigor with practical efficiency to reduce Notified Body queries and streamline submission cycles

Webinar Speakers

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Senior Manager – Medical Device Services, Celegence

Smridula Hariharan

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Smridula Hariharan holds a master's degree in pharmacy and brings over 12 years of medical writing experience spanning regulatory affairs, pharmacovigilance, and clinical research. She has extensive expertise in PMS documentation and has supported CE marking under both MDD and MDR for diverse product categories. Her work focuses on clinical evaluations, PMS and PMCF plans, and audit-ready documentation for successful NB submissions.

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Associate Manager – Medical Device Services, Celegence

Dr. Neha Keral

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Dr. Neha Keral is an experienced regulatory professional specializing in clinical evaluation and PMS documentation across global markets, including EU MDR, FDA, TGA, MHRA, and Health Canada. With a Ph.D. in Life Sciences focused on antimicrobial and anticancer research, she combines scientific depth with regulatory insight. At Celegence, she leads documentation processes, mentors writing teams, and ensures high-quality, compliant CER and PMS deliverables.

This session is highly relevant for:

  • Regulatory Affairs and Compliance teams preparing device submissions
  • Clinical Evaluation and Medical Writing professionals responsible for CERs and SLRs
  • Quality Assurance teams overseeing MDR readiness
  • Product / Portfolio Managers aligning documentation strategy with product planning
  • PMS / Vigilance teams integrating clinical evidence into ongoing compliance frameworks