Podcasts
Data Integrity & Quality Culture
In this episode of RCA Radio, host Erika Porcelli and guest Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates (RCA), examine the resurgence of data integrity issues and the focus...
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Case Studies
Brand Name Re-Registration with New Logo
A medical device manufacturer was consolidating its product portfolio, leading to a product and logo change in 15 products distributed across 60 countries.
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Podcasts
AI & Machine Learning in Medical Device
In this episode of RCA Radio, host Erika Porcelli and guest Lisa Michels, General Counsel & Regulatory Affairs Expert at Regulatory Compliance Associates (RCA), examine the FDA's proposed regulatory framework...
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Case Studies
CE Mark: Clinical Evaluation
Devicor, the leading breast biopsy device manufacturer, engaged RCA to build a clinical evaluation process.
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Case Studies
Production and Process Control
Background A Fortune 500 biotechnology company faced ongoing challenges during campaign changeovers due to missing parts critical to equipment assembly. These deficiencies frequently led to costly, last-minute part fabrication and...
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