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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Researchers target ocular drug delivery market

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Researchers target ocular drug delivery market


Researchers have developed a drug delivery device which attaches to the eye and could negate the need for repeat injections. The team from the University of Southern California has created a simple polymer device which is inserted under the conjunctiva and delivers a therapeutic to the affected area.


In time the device could come to replace the intravitreal injections which patients suffering from glaucoma and related eye diseases currently have to be administered with. 

Ellis Meng, researcher on the project, was keen to emphasise further refinements are in the pipeline. She said: "This prototype isn't optimally sized; it's our first go at proving the concept. We're now building a next-generation device." 

The one centimetre long prototype consists of a refillable reservoir sutured to the sclera which contains the therapeutic. Leading off this is a flexible tube which is inserted into the side of the eye and through which the drug is delivered.

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