Quality Systems
193 articles
PSUR Under EU MDR Article 86: 2026 Periodic Safety Update Report Guide
Prepare an EU MDR Article 86 PSUR with class-based frequency, MDCG 2022-21 structure, EUDAMED submission, PMS data, and benefit-risk analysis.
QA vs QC in Medical Devices: Roles, Responsibilities, and QMSR Impact
Compare QA and QC in medical device manufacturing, including process vs product focus, team roles, tools, organizational structure, and QMSR alignment.
Quality Culture in Medical Devices: Leadership Practices Under FDA QMSR
Build medical device quality culture with leadership practices, ISO 13485 management responsibility, behavioral indicators, audits, and FDA QMSR expectations.
Medical Device Quality Investigation Guide: Complaints, NCRs, and Audit Findings
Conduct medical device complaint, NCR, and audit finding investigations with root cause methods, CAPA, and ISO 13485, FDA 21 CFR 820, and EU MDR alignment.
Quality KPIs and Metrics for Medical Devices: ISO 13485 and QMSR Guide
Build medical device quality KPIs for CAPA effectiveness, first pass yield, complaints, design controls, cost of quality, and ISO 13485 and QMSR alignment.
Medical Device Quality Manual Guide: ISO 13485 Clause 4.2.2 Requirements
Write an ISO 13485:2016 medical device quality manual covering scope, procedures, QMS interactions, exclusions, FDA QMSR considerations, and template structure.
Root Cause Analysis for Medical Devices: RCA Methods, Tools, and CAPA Integration
Guide to medical device root cause analysis, covering 5 Whys, fishbone diagrams, fault tree analysis, Pareto charts, CAPA links, and FDA 483 risks.
Medical Device Traceability Matrix: User Needs to V&V Guide
Build a medical device traceability matrix linking user needs, design inputs, risk controls, and V&V for FDA, ISO 13485, IEC 62304, and EU MDR.
Medical Device Training Management: ISO 13485, FDA QMSR & Competency
Guide to medical device training management under ISO 13485 and FDA QMSR, with competency requirements, effectiveness checks, e-training, and audit readiness.
21 CFR Part 11 Compliance Guide: Electronic Records and Signatures for Medical Devices
FDA 21 CFR Part 11 guide for medical device electronic records, e-signatures, audit trails, system validation, CSA expectations, ISO 13485, and QMSR alignment.
Document Control for Medical Devices: FDA, ISO 13485, and EU MDR
Guide to document control for medical device companies, covering ISO 13485 clause 4.2, FDA 21 CFR 820.40, eQMS use, change control, version control, and audit findings.
Nonconformance Management for Medical Devices: NCR, Disposition, and CAPA
Medical device nonconformance management covering FDA QMSR, ISO 13485 clause 8.3, NCR writing, disposition, MRB review, CAPA escalation, and audit findings.
Single-Use Device Reprocessing & Remanufacturing: FDA & EU MDR Regulatory Guide (2026)
Guide to FDA and EU MDR rules for single-use device reprocessing, covering 510(k)/PMA needs, Article 17, Common Specifications, cost savings, and 2026 EU changes.
ISO 13485 Certification Budget, Auditor Expectations, and Registrar Selection
Plan ISO 13485 certification budgets with 2026 cost ranges, auditor expectations, certification body selection tips, ISO 9001 differences, and FDA QMSR context.
MDSAP Audit Preparation: Complete Guide for Medical Device Manufacturers (2026)
Everything you need to prepare for an MDSAP audit — the 2026 updated audit approach (AU P0002.010), QMSR alignment, step-by-step preparation checklist, costs, timelines, and common nonconformities.
FMEA for Medical Devices: Design, Process & Use Risk Analysis Explained
Use FMEA for medical device risk analysis, including DFMEA, PFMEA, UFMEA, ISO 14971 links, RPN scoring, step-by-step execution, and common errors.
Medical Device Complaint Handling: FDA, ISO 13485 & EU MDR Requirements
Guide to complaint handling for medical devices under FDA QMSR, ISO 13485, and EU MDR, covering intake, reportability, CAPA links, records, and audits.
ASEAN Device Entry: Distributor Qualification and Test Report Reuse Matrix
Six-country ASEAN matrix covering distributor licenses, QMS and warehouse requirements, vigilance setup, and where FDA or NMPA test reports may reduce retesting.
Brazil ANVISA Medical Device Cost Breakdown: Fees and Add-Ons (2026)
2026 Brazil ANVISA device cost guide with government fees by class, BGMP audit costs, MDSAP carve-outs, ANATEL and INMETRO add-ons, and Brazilian Registration Holder retainers.
Human Factors Testing for Medical Devices: FDA and IEC 62366 Guide
Plan human factors testing for devices with FDA guidance, IEC 62366-1, formative and summative studies, sample sizes, HF submission categories, and review-ready documentation.