Regulatory

Prepare for CIRCIA cyber incident reporting rules, including 72-hour CISA reports, 24-hour ransomware payment notices, FDA overlap, coverage, and readiness steps.

Review FDA's 2026 weight loss device guidance, including clinical study design, benefit-risk analysis, nonclinical testing, and obesity device strategy.

Overview of MHRA's 2026 device reforms, including CE mark recognition, DORS fees, clinical trial changes and manufacturer compliance steps for Great Britain.

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.

Assess single-use device reprocessing, circular economy benefits, hospital savings, carbon reduction, AMDR data, lifecycle evidence, EU MDR controls, and business case.

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.

Data-driven analysis of FDA medical device warning letter trends from 2024 to 2026, including common violations, QMSR shifts, notable actions, and compliance lessons.

How device sponsors can prepare FDA Diversity Action Plans under FDORA, set enrollment goals, address waiver criteria, and support representative clinical studies.

How to test AI-enabled medical devices for demographic bias, validate fairness statistically, document FDA and EU submissions, and monitor post-market performance.

Build a device cybersecurity response plan covering FDA 21 CFR 806, EU MDR vigilance, CISA timelines, containment, patient safety review, and coordinated disclosure.

Write and execute verification test protocols with clear scope, acceptance criteria, sample size rationale, results, and FDA, EU MDR, and ISO 13485 alignment.

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.

2026 medical device clinical trial cost guide covering per-patient costs, site fees, CRO budgets, IDE preparation, monitoring, pivotal studies, and cost-saving strategies.

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.

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.

Guide to the EU BtX framework under MDCG 2025-9, covering eligibility, application steps, EMA pilot benefits, FDA comparisons, and IVD implications.

Analyze MedTech Europe's May 2026 MDR/IVDR position paper, including breakthrough and orphan pathways, cybersecurity, AI, IVDR concerns, and the legislative process.

Guide to FDA's May 2026 one-day AI inspection pilot using Elsa, including facility selection, screening inspection expectations, differences from standard inspections, and readiness steps.

What device sponsors need to know about FDA's 2026 real-time clinical trials pilot, AI-enabled monitoring, Paradigm Health, and participation readiness.

Guide to Implementing Regulation (EU) 2026/977 for MDR and IVDR Notified Body assessments, including QMS rules, maximum timelines, clock stops, quotes, and recertification.