Mastering the QMSR: Guide to FDA’s 21 CFR Part 820 Harmonization
Mastering FDA QMSR: Guide to 21 CFR Part 820 Harmonization Effective date referenced: February 2, 2026 • Topics: FDA QMSR, 21 CFR Part 820, ISO
Mastering FDA QMSR: Guide to 21 CFR Part 820 Harmonization Effective date referenced: February 2, 2026 • Topics: FDA QMSR, 21 CFR Part 820, ISO
Navigating the 2026 EU MedTech Overhaul: MDR/IVDR Simplification, the AI Act and EUDAMED The EU is reshaping its MedTech framework. Between MDR/IVDR simplification, the Digital
EUDAMED Mandatory in 2026 The European Commission has officially started the countdown to mandatory EUDAMED compliance. With Commission Decision (EU) 2025/2371 now published in the
When ChatGPT Becomes Your Doctor: The Regulatory Blind Spot Harming the Most Vulnerable Main takeaway: People use general‑purpose AI to self‑diagnose. Current rules don’t clearly
DHF, DMR, DHR with DDF, MDF & MDR TD — A Practical Crosswalk Let’s be honest, that title looks like a typo. But for medical
eSTAR Goes Mandatory for De Novo: What the October 2025 Deadline Really Means (And Why You Should Care About the Voluntary Parts) Disclaimer. Practitioner experience
Why Your FDA US Agent Matters More in 2025: What Foreign Manufacturers Are Learning the Hard Way Disclaimer. This article differentiates regulatory law from observed
ISO 18969: What’s Actually Changing in Clinical Evaluation (And When to Prepare) Clinical evaluation has always been foundational to medical device regulation—it’s how we demonstrate
EU MDR 2017/745 • IVDR 2017/746 • MDCG 2019-7 Rev.1 (Dec 2023) Person Responsible for Regulatory Compliance (PRRC) — EU MDR/IVDR Article 15 The PRRC
MDR · IVDR · 2025 Update MedTech MDR/IVDR 2025 Survival Guide: Key Regulatory Changes and Fast-Track Tips NB capacity is improving but still tight; transitional