Resources

As the healthcare industry continues to embrace digital transformation, connected medical devices are becoming more common—and more vulnerable. From insulin pumps and pacemakers to remote monitoring systems and diagnostic tools,...

With the FDA increasing unannounced and remote inspections, continuous inspection readiness is more important than ever. This webinar offers a focused look at preparing your facility, emphasizing internal audits and...

Regulatory Compliance Associates® (RCA) Executive Pharma Compliance Expert & Principal Consultant, Anita Michael, recently shared important FDA updates impacting pharmaceutical manufacturers. With over 25 years of global regulatory and quality...

In today’s rapidly evolving healthcare landscape, connected medical devices—those that transmit, receive, or act on data—represent some of the most innovative yet complex tools entering the market. These products, often...

In this episode of RCA Radio, host Brandon Miller is joined by cybersecurity experts Jason Tugman of Regulatory Compliance Associates® and Mustanir Ali of BSI Group to unpack the evolving...

Background An established pharmaceutical company with a strong background in biologics and biosimilars was preparing to enter Phase 3 clinical trials with a biosimilar product. While their drug development and...