How can scoping help you identify IVDR essentials or critical internal documents needed for IVDR readiness? What are the benefits to beginning the process early? There are many moving pieces needed to write a PER. Therefore we have developed strategies to keep you and your team on track and help assess your own level of preparedness. First, using our CE scoping checklist, we will walk through the necessary documents, SOPs, processes, reports, and templates. Then we will explain how each of these fits into the overall process of preparing to write.
This presentation will emphasize the importance of scoping, discuss how to develop a checklist, and illustrate how scoping may help you identify gaps or missing pieces that could lead to delays or challenges in your PER writing process.
Who Should Watch:
Those Regulatory, Quality and Clinical leaders and teams who are tasked with the development, writing, review or approval of performance evaluation reports for IVDR submissions, and all those interested in learning more about the IVDR essentials needed to write a PER.
Who are the Panelists?
Dr. Sarah Chavez, Principal Medical Writer | Criterion Edge
Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.
If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.
3rd Party Cookies
This website uses Google Tag Manager and Pardot's tracking features to collect information such as the number of visitors to the site, and the most popular pages. Keeping this cookie enabled helps us to improve our website.
Please enable Strictly Necessary Cookies first so that we can save your preferences!