QMSR Guide: FDA 21 CFR 820 & ISO 13485 Harmonization 2026

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QMSR Transition: Harmonizing FDA 21 CFR 820 with ISO 13485:2016— Post-Implementation Guide 2026 A Post-Implementation Compliance and Inspection Readiness Guide for Medical Device Manufacturers — April 2026 Updated April 2026  |  18-minute read  |  Sourced from FDA.gov, Federal Register, and peer-reviewed regulatory guidance 📋 Table of Contents The Day the QSR Died — and What That Means for You Right Now Why the FDA Finally Made This Move Incorporation by Reference: What It Actually Means in Practice The Terminology Shift: A Complete Comparison Table ISO 14971 and Risk Management: The Connective Tissue of the New QMS Design and Development: The Most Substantive Change You May Have Missed The End of QSIT — What CP 7382.850 Means for Your Next Inspection The Records FDA Can Now See That It Couldn't Before MDSAP, ISO Certification, and the Global Harmonization Play 5-Point Compliance Che...
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Competition intensifying for diabetes subjects; Acurian

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Competition intensifying for diabetes subjects; Acurian


Acurian, a company that specializes in patient recruiting, has reached a significant business milestone with the addition of more than 50 percent of the country's type 2 diabetes population to its database. 


Approximately 8 million of the estimated 16 million diagnosed type 2 or adult-onset diabetes are already on the company's books. The business maintains a database of almost 40 million patients in total.

According to Rick Malcolm, PhD, CEO of Acurian, "It should come as no surprise that diabetes is one of the most strong indications in our database. However, given the fierce rivalry for research participants in this therapeutic field, the fact that more than half of the nation's type 2 diabetics are present and open to learning about clinical trials is definitely important to note. 

According to him, Acurian can assist trial sponsors in gaining access to huge numbers of diabetic patients so they can successfully recruit the right subsets, such as people of color who have the disease or those who have type 1 diabetes.

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