Blogs
FDA Form 483 Response Guidance Update
In this brief expert walkthrough, we review the FDA’s latest guidance on responding to Form 483 observations and highlight what has changed and what it means for your organization. An...
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Published Articles
Ask the Expert: Enhancing Out-of-Specification Procedures
This Video was published by PharmTech. Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, provide advice on creating a robust...
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Published Articles
Navigating the QMSR Transition: Expert Insights on FDA Compliance, Risk Management, and Global Harmonization
Navigating the FDA's Quality Management System Regulation (QMSR) The FDA's Quality Management System Regulation (QMSR), effective February 2, 2026, aligns U.S. medical device quality system requirements more closely with ISO...
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Published Articles
Designing a Test Plan that Works Globally: A Medtech Makers Q&A
Developing a Strategic Medical Device Testing Plan A well-designed medical device testing plan is essential for demonstrating that a device is safe, effective, and performs as intended throughout its lifecycle....
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Published Articles
Ask the Expert: Investigating Patient Complaints About Combination Products
Investigating Patient Complaints Involving Prefilled Syringes In this episode of Ask the Expert, Susan J. Schniepp of RCA and Siegfried Schmitt of Parexel discuss the challenges of investigating patient complaints...
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Visual Resources
Contamination Control Strategy (CCS) Services
Inspection‑Ready Contamination Control. Built for FDA & EU Annex 1. A strong Contamination Control Strategy (CCS) is essential for protecting patient safety and meeting today’s regulatory expectations. Regulatory Compliance Associates®...
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