Click here to watch the recording of this webinar.
The IVDR has many companies scrambling and feeling a bit disorganized. The new regulations include multiple technical documents, as well as the Performance Evaluation Report (PER). But how do all of these pieces fit together? Given the large volume of submissions that Notified Bodies will be reviewing, and the short review times, organization and clarity are critical for the success of your application.
In this webinar, we discuss the process of writing a PER, with careful attention to the importance of aligning technical documents to create a cohesive, well-organized report. Based on our experience with both the MDR and IVDR, we will discuss timelines, resources, and strategies to build a strong foundation to support your IVDR writing team.
Who are the Panelists?
Dr. Sarah Chavez, Director of IVD and Scientific Writing Services.
Sign up for future webinars here.
Criterion Edge has the expertise and resources to write your clinical or performance evaluation report. Ready for a free consult
Tags: clinical evaluation report, data sufficiency, MDSW, medical device medical device software
Fill out this form, or contact us at info@criterionedge.com, and we would be happy to answer any of your questions as well as book you an appointment to discuss your project needs during a time that works for you.
In this discussion, we provide an overview of how to plan and coordinate change within an organization to meet upcoming EU IVDR regulatory requirements. We will be highlighting key steps involved in helping medical affairs transition to a more rigorous regulatory environments, and how to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
In this discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.
This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.
Read more about our privacy policy here.
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.
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!
