Resources

This presentation provides a comprehensive overview of the FDA’s medical device pre-submission process, a critical step for manufacturers seeking to efficiently bring safe and effective devices to market. This session...

What is a pre-determined change control plan (PCCP)? The FDA recently released a final guidance on regulating AI-enabled medical devices that focuses on how manufacturers can modify these devices after...

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss the new...

In this soundbite from RCA Radio, Erika Porcelli, CEO of Regulatory Compliance Associates® (RCA), provides examples of how different size companies leverage the stage of business they're in to accelerate...

In this episode of RCA Radio, host Brandon Miller is joined by Nelson Labs Director of E&L Raymond Colton as well as board certified toxicologist Dr. Sarah Campbell also from...

A contamination control strategy should provide an overview of how contamination and containment practices work together to ensure product quality and patient safety, says Susan J. Schniepp, distinguished fellow at...