Case Studies
Medical Device Validation: Shelf Stability
Background A large medical products manufacturer encountered a critical issue during the development of a new blood collection device. Accelerated shelf-age validation testing revealed that the protective sheath surrounding the...
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Podcasts
Outsourcing Surveillance
In this episode of RCA Radio, host Erika Porcelli and guest Steve Cox, a Regulatory Compliance Associates (RCA) Senior Consultant, cover the business strategy of outsourcing surveillance in both the...
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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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