[FREE WEBINAR SERIES] How to Assess Your CER for MDR Readiness

In the first installment of this webinar series, Criterion Edge presents strategies for assessing key components of your CER (or CER template) for possible misalignment with significant and applicable MDR requirements. This practical presentation will help you assess your document through the critical lens of a writer and identify possible gaps for mitigation before submission to regulatory authorities.

In the second installment, we continue to present strategies for assessing key components of your CER for possible misalignment with key EU MDR requirements, examining the clinical data sources, equivalence, and risk/benefit analysis profile sections of the CER.

Finally, in the third presentation we share with you some of the biggest issues we have discovered when starting an MDR CER project based on our experiences with clients both large and small, and we also reveal some of the most successful strategies in addressing these issues, up-front and early.

Click here to watch our free webinar series to develop MDR-ready CERs.

Key Takeaways:

  • The critical inputs needed to enable the success of your CER and the impact to the project if these inputs are not available or incomplete  
  • Strategically review a CER for clearly stated purpose statements, clear documentation of methodology and logical flow and organization 
  • Apply review strategies to help evaluate your CER for alignment with MDR requirements
  • Why organization, structure and clear language really matter in your CER
  • How to identify those hidden gaps in resources, information and the steps to take to mitigate them 

Who should watch this webinar? 

All regulatory, clinical, and scientific professionals who are tasked with the development, writing, review or approval of scientific manuscripts, reports, presentations, and other forms of communications in the medical device, pharmaceutical, and diagnostics space.

Sign up for future webinars here.

Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

Tags: , , , , , ,

[Free Webinar] IVDR Readiness: Creating a Blueprint to Build a Strong PER

Join us on Wednesday, June 7th, 2023 at 11 AM PST, as our regulatory experts discuss the process of writing a PER, with careful attention to the importance of aligning technical documents to create a cohesive, well-organized report.

Spots are limited – click to register for this free webinar.

Check out our Events Calendar for our upcoming webinars.

Named the #1 Regulatory Services Company 2022 by Life Sciences Review