United States
429 articles
Medical Device Third-Party Cybersecurity Risk Management Guide
Manage third-party cybersecurity risk for connected medical devices using FDA Section 524B, QMSR and ISO 13485 controls, SBOMs, vendor assessments, and threat modeling.
AR/VR Medical Devices: FDA Pathways, Classification, and 2026 Guide
Guide to AR and VR medical device regulation in 2026, including FDA classification, product codes, 510(k) and De Novo routes, cleared devices, surgical navigation, therapeutic VR, and human factors.
Regulatory Affairs Career Guide for Medical Devices: Paths, Salaries, Skills
Career guide for medical device regulatory affairs, covering role progression, salary ranges, RAC certification, core skills, and entry strategies for 2026.
Agile vs Waterfall for Medical Device Software: IEC 62304 Audit Evidence
How to choose Agile, Waterfall, or hybrid medical device software development under IEC 62304, with AAMI TIR45 mapping, design controls, and auditor evidence expectations.
Benefit-Risk Analysis for Medical Devices: FDA, EU MDR, and ISO 14971 Decision Framework
Guide to medical device benefit-risk analysis, covering ISO 14971 residual risk, EU MDR AFAP expectations, FDA benefit-risk factors for PMA, De Novo, and 510(k), examples, and documentation.
Medical Device CMO Selection and Quality Agreement Guide
How to select a medical device CMO, define quality agreements, run supplier audits, manage change control, and align outsourced manufacturing with FDA QMSR and ISO 13485.
CPT, HCPCS, and ICD Coding Strategy for Medical Devices: Reimbursement Pathway Guide
Guide to CPT, HCPCS, and ICD coding strategy for medical device reimbursement, including when to seek new codes, AMA and CMS processes, payment systems, and market access planning.
Decentralized Clinical Trials for Medical Devices: FDA and Hybrid Models
How to design decentralized and hybrid clinical trials for medical devices, covering FDA guidance, remote visits, digital endpoints, wearable data, eConsent, and implementation planning.
Design Output Documentation for Medical Devices: Drawings, Specs, BOMs
Guide to medical device design output records, including drawings, specifications, BOMs, acceptance criteria, and traceability to design inputs under FDA QMSR and ISO 13485.
Design Review Evidence for Medical Devices: Agenda, Minutes, Independence
Guide to medical device design review records, covering agenda planning, meeting minutes, independent reviewers, FDA and ISO expectations, and audit-ready evidence.
Design Transfer to Manufacturing: DMR, Validation, and Supplier Handoff
Guide to medical device design transfer, including DMR readiness, IQ/OQ/PQ process validation, supplier qualification, production handoff, and audit-ready documentation.
EDC Validation for Medical Device Trials: Part 11 and Data Integrity
Guide to validating EDC systems for medical device clinical trials, covering 21 CFR Part 11, audit trails, GAMP 5, IQ/OQ/PQ, ALCOA+ data integrity, sponsor duties, and FDA inspection risks.
eIFU for Medical Devices: EU MDR, FDA Rules, QR Codes, and Paper IFUs
Guide to electronic IFU rules for medical devices, covering EU Regulation 2025/1234, FDA 21 CFR Part 801, website access, QR codes, paper fallback, IVDR, SaMD, and validation.
Fault Tree Analysis for Medical Device Risk Management: FTA vs FMEA
Guide to Fault Tree Analysis under ISO 14971, including FTA vs FMEA, AND/OR gates, probability calculations, examples, and when top-down risk analysis works best.
Hazard Analysis Methods for Medical Devices: FMEA, FTA, PHA, HAZOP
Compare hazard analysis methods for device risk management, including FMEA, FTA, PHA, HAZOP, and use-related analysis under ISO 14971, IEC 62366, FDA, and EU MDR.
ISO/TR 24971 for Medical Devices: Practical Guidance for Applying ISO 14971
Practical guide to ISO/TR 24971:2020 for applying ISO 14971, including hazard identification, risk analysis methods, benefit-risk decisions, and cybersecurity.
Medicare NCD vs LCD for Medical Devices: Coverage Strategy Guide
Compare Medicare NCD and LCD pathways for medical devices, including evidence requirements, timelines, RAPID, Coverage with Evidence Development, MACs, and coverage strategy.
NTAP Application Guide for Medical Devices: Criteria, Timeline, and Strategy
Guide to CMS NTAP for medical devices, covering newness, cost, clinical improvement criteria, MEARIS submission, timelines, payment calculation, and pathway strategy.
Patient-Reported Outcomes in Device Trials: PRO Validation and FDA/EU Expectations
Use PRO instruments in medical device trials with fit-for-purpose validation, endpoint planning, FDA CDRH expectations, EU MDR evidence, and submission strategy.
Risk Management File vs Risk Management Report: ISO 14971 Documentation Explained
Clear guide to ISO 14971 risk management files and reports, including required contents, traceability expectations, document structure, and audit findings.