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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 Takeaways:
- 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
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