Blogs
FDA’s New QMSR Final Rule: What Medical Device Manufacturers Need to Know (2026)
The FDA’s Quality Management System Regulation (QMSR) replaces the legacy QSR and formally incorporates ISO 13485:2016 (and ISO 9000:2015 Clause 3 for terminology) by reference. The final rule was issued...
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Webinars
End-to-End Human Factors for Medical Devices and Re-processing Usability Testing
Human Factors Engineering is essential to designing medical devices and healthcare products that are safe, intuitive, and effective in real-world use. Join Regulatory Compliance Associates (RCA) and Nelson Labs for...
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Published Articles
Ensuring the Supply Chain through Purchasing Controls
The development, quality, and procurement teams should work together to determine which materials and suppliers are needed, says Jane Zhang, Co-Founder & Co-CEO, ETCH Sourcing, and Susan J. Schniepp, distinguished...
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Published Articles
Fundamentals of Batch Recovery Procedures
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, outlines the importance of batch recovery procedures in pharmaceutical manufacturing. Q: What is the best way to...
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Blogs
The Streamlined Approach to Combination Product Compliance
Understanding and Applying the Streamlined QMS Framework In today’s rapidly evolving life sciences landscape, pharmaceutical and biologic companies are increasingly venturing into the world of combination products. These innovative therapies,...
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Published Articles
Audits, Inspections, and CDMOs
In this episode of the Ask the Expert video series hosted by Pharmaceutical Technology®, Susan J. Schniepp, Regulatory Compliance Associates (RCA), Siegfried Schmitt, Parexel, and Anita Michaels, RCA, explain how...
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