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...

About RCA's Strategic Consulting Services Whether it's a corporate needs analysis, corporate growth/transformation initiative or due diligence/acquisition, Regulatory Compliance Associates (RCA®) worldwide experience can help ensure a successful mix of...

About RCA's Remediation Services Regulatory Compliance Associates has significant quality and regulatory compliance consulting experience and a proven regulatory framework for managing FDA 483’s, Warning Letters, and Consent Decrees. Our...

About RCA's Compliance Assurance Services Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators and responding by developing sustainable compliance strategies. Whether it's preparing for an...

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...