Regulatory
411 articles
FDA Section 506J Device Shortage Reporting Guide
Understand Section 506J medical device shortage reporting, including mandatory notifications, the 506J list, OSCR oversight, and supply chain planning.
Ecuador ARCSA Medical Device Registration Guide: 2026 Requirements
Guide to Ecuador ARCSA registration for medical devices and IVDs under the April 2026 rules, covering classification, documentation, fees, timelines, and post-market obligations.
FDA READI-Home Innovation Challenge: Participation Guide
How medical device companies can join FDA's 2026 READI-Home challenge, including eligibility, phases, Q-submissions, and early engagement benefits.
Jordan JFDA Medical Device Registration: Requirements, Process and Timeline
Guide to registering medical devices and IVDs with Jordan's JFDA, covering classification, documentation, process steps, fees, timelines, authorized representatives, and post-market obligations.
CIRCIA for Medical Device Manufacturers: Cyber Incident Reporting to CISA
Prepare for CIRCIA cyber incident reporting rules, including 72-hour CISA reports, 24-hour ransomware payment notices, FDA overlap, coverage, and readiness steps.
FDA Weight Loss Device Guidance 2026: Premarket Evidence Guide
Review FDA's 2026 weight loss device guidance, including clinical study design, benefit-risk analysis, nonclinical testing, and obesity device strategy.
UK MHRA 2026 Overhaul: CE Mark Recognition, DORS Fees and Clinical Trials
Overview of MHRA's 2026 device reforms, including CE mark recognition, DORS fees, clinical trial changes and manufacturer compliance steps for Great Britain.
Health Canada MLMD Guidance 2026: PCCP, Bias, and AI Lifecycle
Guide to Health Canada's 2026 MLMD guidance for AI/ML devices, including PCCPs, data quality, bias controls, lifecycle risk, digital submissions, and FDA/EU comparisons.
Single-Use Device Reprocessing and Medtech Sustainability Guide
Assess single-use device reprocessing, circular economy benefits, hospital savings, carbon reduction, AMDR data, lifecycle evidence, EU MDR controls, and business case.
EU MDR Technical File Deficiencies: Common NB Nonconformities
Guide to common EU MDR technical file deficiencies in Notified Body review, including clinical evidence gaps, risk management, PMS links, equivalence, and 2026/977 timelines.
FDA Medical Device Warning Letter Trends 2024-2026: Enforcement Analysis
Data-driven analysis of FDA medical device warning letter trends from 2024 to 2026, including common violations, QMSR shifts, notable actions, and compliance lessons.
Medical Device Clinical Trial Diversity: FDA Action Plan Guide
How device sponsors can prepare FDA Diversity Action Plans under FDORA, set enrollment goals, address waiver criteria, and support representative clinical studies.
Medical Device AI Bias Testing: Fairness Validation and Documentation
How to test AI-enabled medical devices for demographic bias, validate fairness statistically, document FDA and EU submissions, and monitor post-market performance.
Medical Device Cybersecurity Incident Response and Breach Reporting
Build a device cybersecurity response plan covering FDA 21 CFR 806, EU MDR vigilance, CISA timelines, containment, patient safety review, and coordinated disclosure.
Medical Device Design Verification Test Protocol Guide
Write and execute verification test protocols with clear scope, acceptance criteria, sample size rationale, results, and FDA, EU MDR, and ISO 13485 alignment.
DOJ Medical Device Fraud Enforcement 2026: FCA and Anti-Kickback Risks
Guide to DOJ medical device fraud enforcement in 2026, covering False Claims Act exposure, Anti-Kickback Statute compliance, AI-driven investigations, whistleblower risk, and executive controls.
Medical Device Clinical Trial Cost: 2026 Budget Breakdown
2026 medical device clinical trial cost guide covering per-patient costs, site fees, CRO budgets, IDE preparation, monitoring, pivotal studies, and cost-saving strategies.
Human Factors Content for FDA Medical Device Marketing Submissions
Guide to what human factors evidence to include in FDA 510(k), De Novo, or PMA submissions, including HF categories, critical tasks, use-risk analysis, validation testing, and documentation.
FDA Patient Preference Information for Medical Devices: 2026 Final Guidance
Guide to FDA Patient Preference Information for medical devices under the 2026 final guidance, including collection methods, validation, regulatory submissions, benefit-risk use, and EU alignment.
EU Breakthrough Device (BtX) Designation: MDCG 2025-9 and EMA Pilot Guide
Guide to the EU BtX framework under MDCG 2025-9, covering eligibility, application steps, EMA pilot benefits, FDA comparisons, and IVD implications.