Click here to watch this webinar series.
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.
- 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?