Quality Systems
241 articles
FDA Medical Device Recalls: Corrections, Removals, and Classification
Guide to FDA medical device recalls under 21 CFR 7, 806, and 810, including voluntary and mandatory recalls, Class I/II/III classification, reporting, strategy, and compliance.
ISO 13485 Internal Audit Guide: Checklist, Process, and Best Practices
Guide to ISO 13485 internal audits, including Clause 8.2.4 expectations, audit planning, checklists, auditor qualifications, nonconformities, CAPA linkage, and certification readiness.
FDA Medical Device Reporting: Adverse Event Rules Under 21 CFR Part 803
Guide to FDA Medical Device Reporting under 21 CFR Part 803, including reportable events, 30-day and 5-day deadlines, eMDR submissions, MAUDE, and enforcement risk.
Medical Device Change Control: FDA and EU MDR Requirements
Guide to medical device change control for design, process, and regulatory changes, including FDA QMSR, EU MDR significant changes, Notified Body notification, and best practices.
Medical Device Technical File: EU MDR Documentation Guide
Prepare EU MDR technical documentation for medical devices, including Annex II and III content, FDA DHF comparisons, STED format, ISO 13485 files, and practical assembly steps.
Top Medical Device Consulting Firms: Choose a Regulatory & Quality Partner
Compare medical device consulting firms in 2026 across regulatory affairs, quality systems, clinical strategy, market access, pricing, and selection criteria.
Medical Device Quality Audits: FDA, ISO 13485, EU MDR and MDSAP
Prepare for medical device quality audits, including FDA QMSR inspections, ISO 13485, EU MDR notified body audits, MDSAP, internal audits, findings, and remediation.
Medical Device Process Validation: IQ, OQ, PQ, and the Complete Implementation Guide
Implement medical device process validation with IQ, OQ, and PQ methods, FDA and GHTF expectations, statistical tools, master plans, and continued process verification.
Medical Device Supply Chain Risk Management and Supplier Quality
Manage medical device supply chain risk with supplier qualification, risk assessment, dual sourcing, quality agreements, FDA and ISO 13485 controls, and resilience planning.
CAPA for Medical Devices: Corrective and Preventive Action Complete Guide
CAPA guide for medical device quality systems, covering FDA QMSR, ISO 13485 clause 8.5, root cause analysis, CAPA steps, effectiveness checks, and common audit findings.
DHF, DMR, and DHR: Essential Medical Device Documentation Guide
Guide to DHF, DMR, and DHR documentation for medical devices, including FDA requirements, ISO 13485 equivalents, record contents, relationships, and practical implementation.
Supplier Quality Management for Medical Devices: Audits, Qualification, and Controls
Medical device supplier quality guide covering FDA and ISO 13485 purchasing controls, qualification, audits, agreements, risk controls, and MDSAP expectations.
Design Controls for Medical Devices: FDA Requirements, Process, and Implementation Guide
The complete guide to medical device design controls — FDA 21 CFR 820.30, ISO 13485 clause 7.3, the design control process, DHF requirements, traceability, and practical implementation.
ISO 13485 vs ISO 9001: Key Differences, Requirements, and Which Standard You Need
A detailed comparison of ISO 13485 and ISO 9001 — clause-by-clause differences, regulatory requirements, when you need each standard, and how to transition between them.
Medical Device GMP: Manufacturing Requirements, FDA Inspections, and Compliance Guide
The complete guide to Good Manufacturing Practice for medical devices — 21 CFR 820, QMSR transition, process validation, FDA inspections, Form 483 observations, and practical compliance strategies.
ISO 14971 Risk Management for Medical Devices: The Complete Guide
A comprehensive guide to implementing ISO 14971 risk management for medical devices — from hazard identification through risk control to post-production monitoring.
Health Canada Medical Device License: The Complete Guide
How to obtain a Medical Device License from Health Canada — classification, MDSAP requirements, MDEL, application process, fees, and practical guidance for the Canadian market.
ISO 13485 Certification: Complete Guide for Medical Device Companies
Guide to ISO 13485 certification requirements, audit process, costs, timelines, registrar selection, common findings, and alignment with FDA QSR, EU MDR, and MDSAP.
MDSAP Audit: The Complete Guide to the Medical Device Single Audit Program
Everything about MDSAP — the single audit program covering FDA, Health Canada, TGA, ANVISA, and MHLW. Audit process, grading, preparation, costs, and how to pass.
FDA's QSR to QMSR Transition: What Medical Device Companies Need to Know
The FDA is aligning its Quality System Regulation with ISO 13485. Here's what the QMSR final rule means for your quality management system and what you need to do to prepare.