MedDeviceGuide — IVD & Medical Device Knowledge Base
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.
NGS Bioinformatics Pipeline Change Control: Documentation and Revalidation Guide
Document NGS bioinformatics pipeline changes, assess validation impact, control software and database updates, and prepare IEC 62304 audit records for IVDs.
PCCP Drift Monitoring for AI Imaging Devices: Thresholds and Retraining Triggers
Build FDA PCCP drift monitoring protocols for AI imaging devices, including dataset shift, scanner drift, thresholds, cadence, retraining triggers, and submission boundaries.
PMCF Survey Design: Evidence Level, Sample Size, Endpoints, and Bias Controls
Design EU MDR PMCF surveys that Notified Bodies accept, with sample frames, CER endpoint mapping, acceptance criteria, statistics, bias controls, and adverse event capture.
QMSR Supplier Quality Agreements for Cloud, AI, Cybersecurity, and Test Vendors
Draft QMSR supplier quality agreements for cloud, AI, cybersecurity, testing, and sterilization vendors with audit, CAPA, change notice, and evidence clauses.
RUO-to-IVD Conversion Firewall: Convert Research-Use Assays Without Evidence Risk
Operational guide to converting RUO assays into regulated IVDs, covering claims cleanup, distributor controls, data triage, validation bridging, training, and evidence firewalls.
SBOM-to-VEX Vulnerability Triage Workflow for Medical Device PSIRTs
PSIRT playbook for medical device SBOM-to-VEX triage, covering CVE intake, component matching, exploitability analysis, VEX rationale, severity scoring, CAPA, field action, and communications.
Special 510(k) for Software and Cybersecurity Changes: Decision Tree and Evidence Package
Decision tree for when a software or cybersecurity update can use Special 510(k) vs Traditional 510(k) — risk analysis, V&V summary, FDA guidance, and evidence package requirements.
SSCP Notified Body Deficiency Response Pack for EU MDR
Playbook for responding to Notified Body SSCP deficiencies under EU MDR, covering response tables, clinical benefit wording, residual risk, readability, CER/IFU alignment, and EUDAMED readiness.