Case Studies
ÃÛ¶¹ÊÓƵ 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 ÃÛ¶¹ÊÓƵ 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 ÃÛ¶¹ÊÓƵ 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 ÃÛ¶¹ÊÓƵ
In this episode of RCA Radio, host Erika Porcelli and guest Lisa Michels, General Counsel & ÃÛ¶¹ÊÓƵ Affairs Expert at ÃÛ¶¹ÊÓƵ 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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