Future-Proof Your CERs for 2026: Meet Notified Body Expectations for Audit-Ready SLRs | Webinar

Medical device manufacturers are entering a new phase of regulatory scrutiny. As we approach 2026, Notified Bodies are placing stronger emphasis on the scientific defensibility, traceability, and completeness of Clinical Evaluation Reports (CERs).

In this webinar, Celegence experts Smridula Hariharan and Dr. Neha Keral break down the key elements of building CERs and systematic literature reviews (SLRs) that withstand deeper review and minimize follow-up queries.

What this session covers:

1. How to define and justify clinical and performance endpoints using clear logic
2. Approaches for handling zero-event data, confidence intervals, and acceptance criteria
3. Building reproducible, high-quality SLRs aligned with regulatory expectations
4. Strengthening traceability from claims → evidence → risk management → PMS
5. Practical ways to maintain efficient, audit-ready CER workflows using digital tools
6. Creating a balanced 2026 CER strategy that supports smoother submissions

Who should watch:
Regulatory Affairs teams, Clinical Evaluation specialists, Medical Writers, QA/Compliance teams, PMS/Vigilance teams, and Product/Portfolio managers working toward MDR-ready documentation.

Speakers:
1. Smridula Hariharan – Senior Manager, Medical Device Services, Celegence
2. Dr. Neha Keral – Associate Manager, Medical Device Services, Celegence

For more insights on CERs, SLRs, PMS, and MDR compliance, visit: https://www.celegence.com

Видео Future-Proof Your CERs for 2026: Meet Notified Body Expectations for Audit-Ready SLRs | Webinar канала Celegence