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2025 Medical Device Outlook
Manage episode 463416504 series 2807097
In this episode of RCA Radio®, host Brandon Miller is joined by Rod Mell, Executive Head – Life Science Consulting at RCA, as well as Jordan Elder, Director of Regulatory both at Regulatory Compliance Associates. We explore possible changes in the Medical Device industry in 2025 and provide you with insight on how to prepare yourself for these upcoming initiatives.
Listen in as we go over updated EU MDR / EUDAMED timelines, recent and upcoming final guidance documents, the strategic priorities outlined by the FDA, the Quality Management System Regulation (QMSR Final Rule), the agency inspection focuses, and how companies can prepare themselves for success with the incoming changes.
About RCA
Regulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory, compliance, quality, and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
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