There’s been plenty of discussion on the submission scope of current EU MDR and pending EU IVDR regulatory requirements for medical device manufactures. But what of organizational change management readiness? How should a medical device organization’s different business functions collaborate and align their people, processes, and knowledge to meet these regulatory requirements effectively and efficiently?
Watch the recorded webinar for a behind the scenes look at how one company is managing change within their organization. Dr. Imelda Omana-Zapata, BD Senior Manager Clinical Projects, will provide an overview of how she is planning and coordinating change within her organization to meet upcoming EU IVDR regulatory requirements. Laurie Mitchell, Founder and President of Criterion Edge, will discuss the critical technology and expertise required to meet more rigorous scientific validated submissions to notify bodies.
Key steps involved in helping medical affairs transition to a more rigorous regulatory environments.
How to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
Critical systematic literature review technology and experience required to ensure CER and PER submissions are audit-ready and compliant.
Who Should Watch:
Medical Device & Diagnostics Professionals (from small-medium sized to large enterprises)
Who are the Panelists?
Laurie Mitchell, President | Criterion Edge Dr. Imelda Omana-Zapata, Senior Manager, Clinical Projects | BD
[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.
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!