Medical Device & IVD Blog
FDA One-Day AI Inspection Pilot: How Elsa Is Reshaping Medical Device Facility Oversight
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.
FDA Real-Time Clinical Trials Pilot for Medical Devices
What device sponsors need to know about FDA's 2026 real-time clinical trials pilot, AI-enabled monitoring, Paradigm Health, and participation readiness.
EU Implementing Regulation 2026/977: Uniform Notified Body Requirements Under MDR and IVDR
Guide to Implementing Regulation (EU) 2026/977 for MDR and IVDR Notified Body assessments, including QMS rules, maximum timelines, clock stops, quotes, and recertification.
IVDR Class C Transition Deadline: What IVD Manufacturers Must Do Before May 26, 2026
Practical guide to the May 26, 2026 IVDR Class C deadline, covering Notified Body applications, the September 2026 agreement milestone, 2028 market access, and key pitfalls.
MDCG 2026 Updates: Classification, EMDN Codes, and Borderline Guidance
Practical guide to April 2026 MDCG updates on MDR/IVDR classification, EMDN v3/2026 codes, the Borderline Manual, and manufacturer compliance actions.
Auto-Injector Critical-Task Matrix for Human Factors Validation
Guide to auto-injector critical-task matrices for human factors validation, including URRA inputs, dose confirmation, hold time, misfire recovery, training decay, and FDA evidence expectations.
EPA Ethylene Oxide Rules for Medical Device Sterilization: 2026 Guide
Guide to the EPA's 2026 proposed EtO emissions rollback for medical device sterilization, covering the 2024 rule, compliance timelines, supply chain risk, and alternatives.
eSTAR Additional Information Response Playbook for FDA Deficiency Letters
Playbook for answering FDA Additional Information requests in eSTAR 510(k) and De Novo submissions, covering response tables, file naming, version control, section mapping, and traceability.
EU AI Act and MDR Single Evidence Matrix for AI Medical Devices
Guide to building one evidence matrix for AI medical devices under EU MDR and the EU AI Act, mapping Annex II/III files, ISO 14971 risks, PMS/PMCF, cybersecurity, data governance, and QMS evidence.
EUDAMED Bulk Upload Validation Error Playbook: Fix XML Rejections
Playbook for diagnosing EUDAMED bulk upload validation errors, including XSD failures, UDI mismatches, EMDN issues, certificate links, DTX codes, and pre-upload checks.
FDA AI-Enabled Device Predicate Mining for 510(k) and De Novo
Method for mining FDA AI-enabled device and 510(k) databases to identify predicates, compare technology, avoid weak arguments, and build a defensible predicate matrix.
FDA ASCA Test Report Acceptance Package for 510(k) and De Novo
Step-by-step guide to ASCA evidence packages for 510(k) and De Novo submissions, including summary test reports, declarations, lab accreditation, scope matching, and FDA questions.
FDA Cybersecurity Unresolved Anomalies Table for Premarket Submissions
Guide to building an FDA unresolved software anomalies table for cybersecurity submissions, including CVSS, exploitability, clinical impact, controls, SBOM links, VEX status, and labeling.
FDA Third Party Review Program: 510(k) Due Diligence Checklist
Evaluate whether 3P510k review fits your device, with checks for product code eligibility, Accredited Person conflicts, eSTAR fit, timing, and risk.
GB PMSR/PSUR Dual Reporting for EU and UK Medical Devices
Structure PMSR and PSUR reports for devices sold in the EU and Great Britain, covering data periods, MHRA format, GB content, FSCA links, and retention.
Home-Use IVD Invalid Result Workflow for Consumer Diagnostics
Design and monitor invalid-result workflows for home-use IVDs, including invalid rates, lay-user errors, repeat testing, IFU comprehension, support scripts, and postmarket trending.
IEC 62304 Edition 2: 2026 Software Lifecycle Changes for Devices
Prepare for IEC 62304 Edition 2 with process rigor levels, broader health software scope, AI/ML lifecycle provisions, cybersecurity integration, and compliance timelines.
IVDR Companion Diagnostic Consultation File: NB-EMA/NCA Package Guide
Prepare an IVDR companion diagnostic consultation file for NB submission, covering EMA/NCA review, contents, performance evidence, drug label alignment, timing, and deficiency risks.
MDR Article 88 Trend Reporting: Statistical Thresholds and Workflow
How to set MDR Article 88 trend reporting thresholds, choose denominators, test significance, escalate severity, link CAPA, and align PMSR/PSUR outputs.
MDUFA VI: FDA Device User Fees and 2027-2032 Reauthorization
Guide to MDUFA VI for 2027-2032, covering FDA device user fee changes, CDRH staffing, real-world evidence provisions, fee projections, and preparation steps.