United States

Regulatory, commercial, and privacy risk guide for direct-to-consumer (DTC) genetic testing companies — covering FDA oversight of DTC IVDs, wellness vs. medical claims boundaries, analytical and clinical validity requirements, risk report authorization, GINA and state privacy laws, FTC advertising substantiation, 23andMe bankruptcy data precedent, and practical guidance on claims that change regulatory status.

Practical regulatory guide for home-use and self-test in vitro diagnostic devices — covering FDA pathways (OTC, prescription home use, CLIA waiver), EU IVDR self-testing requirements, human factors and lay-user usability, specimen collection errors, labeling requirements, DTC vs provider-ordered models, and post-market surveillance for consumer diagnostics.

Manufacturer-facing guide to reprocessing validation for reusable medical devices under ISO 17664-1, ISO 17664-2, FDA guidance, and EU MDR — covering cleaning, disinfection, sterilization validation, worst-case device families, IFU content, and premarket submission evidence.

Protocol-level analytical validation guide for IVD manufacturers — covering test plan tables, acceptance criteria, sample selection, statistical methods per CLSI standards, and FDA/EU IVDR expectations for analytical performance evidence.

Regulatory and risk assessment guide for medical devices incorporating nanomaterials — covering EU MDR Rule 19 classification, FDA nanotechnology guidance, ISO 10993-22 biocompatibility, SCENIHR exposure framework, nanotoxicology testing, sterilization challenges, labeling requirements, and a decision tree for regulatory strategy.

Comprehensive regulatory and validation strategy for next-generation sequencing (NGS) in vitro diagnostic devices — covering FDA pathways (510(k), De Novo, PMA), proposed CDx reclassification, EU IVDR classification, wet lab and bioinformatics pipeline validation, variant calling, reference databases, clinical validity, cybersecurity, and post-market obligations.

Comprehensive regulatory strategy guide for pre-filled syringes and auto-injectors as drug-device combination products — covering FDA OCP/RFD jurisdiction, ISO 11608 design verification, human factors validation, EU MDR Article 117, QMSR quality system implications, stability testing, and lifecycle change management.

Step-by-step guide to writing reprocessing instructions for reusable medical device IFUs — covering point-of-use treatment, cleaning, disinfection, sterilization, drying, storage, reuse life claims, warnings, usability validation, and audit readiness per FDA guidance, ISO 17664, and ISO 20417.

Regulatory strategy guide for surgical robot manufacturers — covering FDA classification (510(k), De Novo, PMA), autonomy levels, software controls (IEC 62304), electrical safety (IEC 60601), usability (IEC 62366), clinical evidence expectations, EU MDR requirements, training programs, and post-market surveillance.

Practical labeling and intended-use boundary guide for IVD manufacturers — covering FDA RUO/IUO guidance, clinical diagnostic use triggers, enforcement actions, marketing language risk, distributor behavior, and a decision tree for regulatory classification.

Comprehensive supplier audit checklist for medical device manufacturers — covering supplier risk classification, qualification, audit agenda, purchasing controls per ISO 13485 Clause 7.4 and FDA QMSR, quality agreements, outsourced sterilization/testing/software, CAPA follow-up, and evidence records.

Equipment and process validation guide for washer-disinfectors in medical device reprocessing — covering ISO 15883 series parts 1–7, IQ/OQ/PQ methodology, A₀ value concept, load configurations, chemical dosing, temperature monitoring, microbiological endpoints, maintenance, and deviation handling.

FDA's February 2026 cybersecurity guidance and Section 524B of the FD&C Act make penetration testing, vulnerability scanning, and fuzz testing mandatory evidence for connected medical device submissions. This guide covers what testing is required, how to structure results, common FDA deficiencies, EU MDR cybersecurity expectations, and how to build a testing program that satisfies both regulatory frameworks.

On April 23, 2026, CMS and FDA announced the RAPID pathway — a new initiative that could deliver Medicare national coverage within 60–90 days of FDA authorization for eligible Breakthrough Devices. This guide explains eligibility requirements, how the pathway works, IDE study design implications, and what manufacturers must do to prepare.

On February 3, 2026, the FDA reissued its premarket cybersecurity guidance aligned with the new Quality Management System Regulation (QMSR) and ISO 13485:2016. This guide covers what changed, what stayed the same, how to map cybersecurity to ISO 13485 clauses, and practical steps for manufacturers building connected devices in 2026.

On January 6, 2026, the FDA significantly expanded its General Wellness policy, now allowing certain wearable devices that estimate blood pressure, blood glucose, oxygen saturation, and other physiologic parameters to qualify as non-regulated wellness products. This guide covers the new criteria, FDA's illustrative examples, the line between wellness and medical device claims, and what manufacturers must do to stay compliant.

Data-driven analysis of medical device recall trends through 2024–2026 — 1,059 recall events, Class I recalls at a 15-year high, device failure as the new #1 cause, ~440 million units affected (up 55%), software defect trends, FDA early alert pilot, and risk mitigation strategies for manufacturers.

Complete guide to third-party vendor cybersecurity risk management for medical devices — FDA Section 524B, QMSR ISO 13485 alignment, SBOM requirements, vendor risk assessment frameworks, MITRE threat modeling, and implementation strategies for connected device manufacturers.

Complete guide to augmented reality and virtual reality medical device regulation — FDA classification, product codes, 510(k) vs De Novo pathways, the 104 FDA-cleared AR/VR devices, surgical navigation, therapeutic VR, and human factors requirements in 2026.

Complete career guide for medical device regulatory affairs professionals — career paths from entry level to VP, salary ranges by role and region, RAC certification details, essential skills, and how to break into the field in 2026.