Global
57 articles
Top Medical Device Companies in 2026: Revenue Rankings, Market Share, and Industry Trends
A comprehensive guide to the world's largest medical device companies ranked by revenue — including Medtronic, Johnson & Johnson, Abbott, Siemens Healthineers, and more — with 2026 market data, strategic shifts, and what's driving growth.
ISO 13485 Internal Audit Guide for Medical Device Manufacturers: Checklist, Process, and Best Practices
Complete guide to ISO 13485 internal audits — Clause 8.2.4 requirements, audit planning, checklist by clause, auditor qualifications, nonconformity classification, CAPA integration, and preparation tips for certification audits.
Top Medical Device Consulting Firms: How to Choose the Right Regulatory & Quality Partner in 2026
Comprehensive guide to the leading medical device consulting firms in 2026 — covering regulatory affairs, quality systems, clinical strategy, and global market access. Includes detailed firm profiles, comparison tables, pricing insights, evaluation criteria, and a decision framework for choosing the right partner.
Medical Device Quality Audits: The Complete Guide to FDA Inspections, ISO 13485, EU MDR, MDSAP & Internal Audits
The definitive guide to quality audits for medical devices — covering FDA QMSR inspections, ISO 13485 certification audits, EU MDR Notified Body audits, MDSAP, internal audits, supplier audits, audit findings classification, preparation timelines, and post-audit remediation.
Medical Device Policy & Legislation: Key Laws Shaping the Industry in 2026
Navigate the evolving medical device legislative landscape — from MDUFA V and the VALID Act to EU MDR implementation challenges, AI regulation, and global policy trends reshaping how devices reach patients.
Point-of-Care Testing (POCT): Regulatory Requirements, CLIA Waivers, and Market Trends
Comprehensive guide to point-of-care testing regulation — CLIA waiver requirements, FDA review pathways for POCT devices, EU IVDR classification, quality management, and the rapidly growing near-patient testing market.
Sustainability & ESG in Medical Devices: Regulatory Drivers, Circular Economy, and Industry Best Practices
How environmental sustainability, ESG reporting, and circular economy principles are transforming medical device design, manufacturing, and regulation — covering EU CSRD, FDA green initiatives, lifecycle assessment, and practical implementation strategies.
AI/ML in Medical Devices: FDA Regulatory Framework, SaMD Classification, and Approval Pathways
The complete guide to artificial intelligence and machine learning in medical devices — FDA's AI/ML action plan, predetermined change control plans, SaMD classification, 510(k) and De Novo pathways, EU MDR requirements, and Good Machine Learning Practice.
CAPA for Medical Devices: Corrective and Preventive Action Complete Guide
The definitive guide to CAPA in the medical device industry — FDA 21 CFR 820.198, ISO 13485 clause 8.5, root cause analysis methods, CAPA process steps, effectiveness checks, and common audit findings.
DHF, DMR, and DHR: Essential Medical Device Documentation Guide
Complete guide to the Device History File (DHF), Device Master Record (DMR), and Device History Record (DHR) — FDA requirements, ISO 13485 equivalents, contents, relationships, and practical implementation.
IEC 62366 Usability Engineering for Medical Devices: Complete Guide
The definitive guide to usability engineering for medical devices — IEC 62366-1:2015, FDA human factors guidance, usability engineering file, formative and summative evaluations, use-related risk analysis, and EU MDR usability requirements.
Supplier Quality Management for Medical Devices: Audits, Qualification, and Controls
The complete guide to supplier quality management in the medical device industry — FDA requirements, ISO 13485 clause 7.4, supplier qualification, audit programs, supplier agreements, risk-based 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.
In Vitro Diagnostic (IVD) Devices: The Complete Regulatory Guide for FDA and EU IVDR
Everything you need to know about IVD device regulations — FDA classification, EU IVDR classes A-D, performance evaluation, companion diagnostics, LDTs, and global regulatory requirements.
Medical Device Cybersecurity: FDA Requirements, SBOM, Threat Modeling, and Compliance Guide
The complete guide to medical device cybersecurity regulations — FDA Section 524B requirements, SBOM, threat modeling, premarket submissions, post-market vulnerability management, and EU MDR cybersecurity obligations.
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.