Medical Device & IVD Blog

Complete step-by-step guide to implementing ISO 13485:2016 from scratch. Covers all 8 clauses, documentation hierarchy, certification process (Stage 1 and Stage 2 audits), costs ($5K-$60K+), timeline (6-24 months), notified body selection, and alignment with FDA QMSR effective February 2026.

A comprehensive guide to ISO 14155:2026 for medical device clinical investigations — the 4th edition's risk management integration, Clinical Events Committees, estimand framework, sponsor and investigator responsibilities, adverse event reporting, and post-market study requirements.

A comprehensive guide to ISO 15223-1:2021 medical device labeling symbols — the 2025 Amendment 1 EU REP change, complete symbol reference by category, MDR/IVDR compliance requirements, symbol validation per ISO 15223-2, and practical implementation for manufacturers.

A comprehensive guide to ISO 17665 steam (moist heat) sterilization — process physics, the 2024 consolidated standard, IQ/OQ/PQ validation, F0 lethality calculations, biological indicators, overkill vs bioburden-based cycles, autoclave qualification, and routine monitoring.

Complete guide to laboratory developed test regulation in 2026 — FDA's vacated 2024 final rule, the ACLA court decision, current CLIA oversight, enforcement discretion status, and what laboratories must do now.

How to conduct management reviews for medical device companies per ISO 13485 Clause 5.6 and FDA QMSR — required inputs, outputs, frequency, documentation, and common audit findings.

How to prepare, structure, and submit a compliant PSUR under MDR Article 86 — frequency by device class, MDCG 2022-21 template walkthrough, EUDAMED submission for Class III and implantables, benefit-risk analysis, PMS data integration, and the 2025 simplification proposal that may change reporting cadence.

Quality Assurance vs. Quality Control in medical device manufacturing — proactive vs. reactive, process vs. product, responsibilities, tools, org structure, and how QMSR 2026 changes the landscape. Includes FDA 21 CFR 820 and ISO 13485 alignment.

How to build and sustain a quality culture in medical device organizations — FDA QMSR Comment 27 expectations, ISO 13485 Clause 5 management responsibility, behavioral indicators, leadership practices, audit methods, and a practical framework for cultural transformation.

How to conduct quality investigations for medical devices — complaint handling, nonconformance investigation, audit finding root cause analysis, investigation methods, CAPA integration, and regulatory requirements under ISO 13485:2016, FDA 21 CFR 820, and EU MDR.

How to build a quality KPI framework for medical device companies — CAPA effectiveness, first pass yield, complaint rates, design control metrics, and cost of quality. Fully aligned with ISO 13485:2016 and FDA QMSR 2026 requirements.

How to write a quality manual that satisfies ISO 13485:2016 Clause 4.2.2 — the four mandatory elements, documentation structure, FDA QMSR considerations, common mistakes, and a detailed template outline.

Complete guide to root cause analysis for medical device companies — 5 Whys, fishbone diagrams, fault tree analysis, Pareto charts, CAPA integration, and common mistakes that lead to FDA 483 observations.

Everything medical device manufacturers need to know about Software Bill of Materials — FDA cyber device requirements, NTIA minimum elements, SPDX vs CycloneDX formats, VEX integration, tools, and post-market management strategies.

How to prepare, validate, and publish the Summary of Safety and Clinical Performance (SSCP) under EU MDR Article 32 — MDCG 2019-9 Rev.1 template walkthrough, HCP and layperson sections, readability testing, Notified Body validation process, translation requirements, EUDAMED upload timelines, and common NB findings in 2026.

How to build and maintain a requirements traceability matrix for medical devices — linking user needs, design inputs, outputs, risk controls, verification, and validation under FDA 21 CFR 820.30, ISO 13485:2016, IEC 62304, and EU MDR.

Complete guide to training management in medical device QMS — ISO 13485 Clause 6.2 requirements, FDA QMSR expectations, effectiveness evaluation methods, electronic training systems, and audit-readiness best practices.

Complete guide to FDA 21 CFR Part 11 for medical device companies — electronic records, electronic signatures, audit trails, system validation, CSA guidance, and how Part 11 connects to ISO 13485 and the new QMSR.

The complete guide to document control for medical device companies — ISO 13485 clause 4.2 requirements, FDA 21 CFR 820.40, document lifecycle management, eQMS implementation, change control, version control, and common audit findings.

The complete guide to nonconformance management in medical device manufacturing — FDA 21 CFR 820.90, ISO 13485 clause 8.3, NCR writing, disposition options, Material Review Board, escalation to CAPA, root cause analysis, and common audit findings.