Articles tagged with “iso-13485”

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

Lean Six Sigma and AI in MedTech Quality Assurance

Analyze the integration of AI with Lean Six Sigma in MedTech. Reviews DMAIC enhancements, regulatory compliance, and predictive quality management systems.

30 min read

2/27/2026

lean six sigma artificial intelligence medtech quality iso 13485 dmaic framework machine learning medical device qms quality assurance predictive analytics fda compliance

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

Veeva Vault QMS: CAPA Implementation & Configuration Guide

Configure CAPA management in Veeva Vault QMS with this technical guide. Covers data models, 21 CFR Part 820 compliance, and workflow implementation steps.

40 min read

2/21/2026

veeva vault qms capa management 21 cfr part 820 quality management system root cause analysis iso 13485 capa configuration life sciences quality audit trails regulatory compliance

Veeva Vault QMS: ISO 13485 Compliance for Medical Devices

Examine how Veeva Vault QMS supports ISO 13485 compliance for medical devices. Learn to map digital QMS features to regulatory standards for audit readiness.

25 min read

2/18/2026

veeva vault qms iso 13485 medical device qms 21 cfr part 820 digital quality management regulatory compliance audit readiness design controls

QMS for AI/ML Medical Devices: Regulatory & Design Guide

Learn QMS requirements for AI/ML medical devices, including FDA regulations, ISO 13485, data lifecycle management, and model validation strategies.

55 min read

2/13/2026

ai medical devices machine learning qms samd regulation iso 13485 fda 21 cfr 820 medical device software data validation risk management

Biotech QMS Strategy: Transitioning from Excel to eQMS

Examine the risks of DIY quality systems in biotech. Learn about FDA Part 11 compliance, data integrity, and when to transition from Excel to eQMS software.

45 min read

2/10/2026

biotech qms eqms software data integrity 21 cfr part 11 quality assurance regulatory compliance iso 13485 life sciences

Deviations, CAPA, and Change Control: A Workflow Guide

Learn the integrated workflow for manufacturing deviations, CAPA, and change control in GMP. This guide covers regulatory requirements and common inspection pit

40 min read

1/6/2026

capa change control manufacturing deviation quality management system gmp root cause analysis regulatory compliance iso 13485

IEC 62304 vs FDA CSA: A Medical Software Compliance Guide

Compare the IEC 62304 standard vs. FDA CSA guidance for medical software. Learn key differences in scope, risk classification, validation, and documentation.

35 min read

12/28/2025

iec 62304 fda csa medical device software software validation 21 cfr 820 qms software regulatory compliance iso 13485

eQMS Maturity Model: A 5-Stage Guide for Biotech & MedTech

Learn the 5-stage eQMS maturity model for Biotech & MedTech startups. This framework guides QMS implementation for FDA and ISO 13485 compliance and scalability.

35 min read

12/17/2025

eqms maturity model biotech qms medtech compliance quality management system fda 21 cfr part 11 iso 13485

What is ISO 13485? A Guide to Medical Device QMS

Learn about ISO 13485:2016, the quality management system (QMS) standard for medical devices. This guide explains its requirements, purpose, and role in complia

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

ISO 9001 in Biotech: A Guide to Relevance & Compliance

Is ISO 9001 still used in biotech? This guide analyzes how the QMS standard supports regulatory compliance, complements GMP, and improves quality in pharma & li

40 min read

11/13/2025

iso 9001:2015 biotechnology quality management system gmp regulatory compliance life sciences iso 13485 pharmaceutical quality