Articles tagged with “fda-qmsr”

FDA QMSR: Internal Audit Reports No Longer Confidential

Learn how FDA QMSR impacts 21 CFR 820. Internal audit and management review records are no longer confidential and subject to inspection under the new rule.

20 min read

2/27/2026

fda qmsr iso 13485 internal audits 21 cfr part 820 medical device regulations fda inspection management review quality management system

FDA QMSR & ISO 13485: New Inspection Playbook Guide

Analyze the FDA QMSR final rule, ISO 13485 alignment, and the new CP 7382.850 inspection playbook. Learn key compliance steps for device manufacturers.

35 min read

2/27/2026

fda qmsr iso 13485 medical device regulation 21 cfr part 820 quality management system fda inspection risk management cp 7382.850 regulatory affairs medtech

FDA QMSR & ISO 13485: Key Changes Effective 2026

Analyze the FDA Quality Management System Regulation (QMSR) effective Feb 2, 2026. Learn how ISO 13485:2016 incorporation impacts medical device compliance.

50 min read

2/27/2026

fda qmsr iso 13485 medical device regulation 21 cfr part 820 quality management regulatory compliance fda inspection device manufacturers

DHF Remediation: QMSR and Medical Device File Transition

Analyze FDA QMSR requirements for DHF remediation. Learn how to transition legacy Design History Files to the ISO 13485 Medical Device File framework.

40 min read

2/26/2026

fda qmsr dhf remediation medical device file iso 13485 design history file device master record 21 cfr part 820 regulatory compliance gap analysis

What is ISO 13485? A Guide to Medical Device QMS

Learn about ISO 13485:2016, the QMS standard for medical devices. Updated for 2026 with FDA QMSR effective date, EU MDR/EUDAMED timelines, AI/ML guidance, and certification data

45 min read

11/14/2025

iso 13485 quality management system medical devices regulatory compliance qms iso 13485:2016 fda qmsr eu mdr risk management

IEC 62304: Medical Device Software Life Cycle Processes

A comprehensive guide to the IEC 62304 standard for medical device software, updated for 2026. Covers life cycle processes, safety classification, Edition 2.0 draft changes, FDA QMSR alignment, IEC 81001-5-1 cybersecurity, and regulatory compliance across FDA and EU MDR.

100 min read

8/25/2025

iec 62304 medical device software software life cycle samd regulatory compliance risk management software safety cybersecurity iec 81001-5-1 fda qmsr