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Background A biological drug development company based in Europe came to RCA as their facility expansion was under construction. A team of RCA experts engaged in guiding this company through...

Whether struggling with a submission strategy and execution or dealing with regulatory compliance, RCA stands ready to support your medical device needs. Our consultants have years of experience as regulatory...

The FDA’s regulatory landscape for medical devices is intricate and continually evolving, especially with the advent of innovative technologies like 3D printing and mobile health applications. This white paper from...

In this episode of RCA Radio, host Brandon Miller is joined by Jordan Elder, ÃÛ¶¹ÊÓƵ Compliance Associates'® (RCA) ÃÛ¶¹ÊÓƵ Expert. Kinga Demetriou, an Expert Certifier at BSI, and Nathan Shipley,...

The quest is on for machine learning (ML) to turn raw data into useful medical devices that improve outcomes and reduce burden on the healthcare system. Supporting, and someday emulating,...

The internal audit function of life science companies is one cornerstone of an effective and efficient quality management system. There are several types of audits that comprise a robust internal...