MedDeviceGuide — IVD & Medical Device Knowledge Base

Guide to building an FDA unresolved software anomalies table for cybersecurity submissions, including CVSS, exploitability, clinical impact, controls, SBOM links, VEX status, and labeling.

Evaluate whether 3P510k review fits your device, with checks for product code eligibility, Accredited Person conflicts, eSTAR fit, timing, and risk.

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.

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.

Prepare for IEC 62304 Edition 2 with process rigor levels, broader health software scope, AI/ML lifecycle provisions, cybersecurity integration, and compliance timelines.

Prepare an IVDR companion diagnostic consultation file for NB submission, covering EMA/NCA review, contents, performance evidence, drug label alignment, timing, and deficiency risks.

How to set MDR Article 88 trend reporting thresholds, choose denominators, test significance, escalate severity, link CAPA, and align PMSR/PSUR outputs.

Guide to MDUFA VI for 2027-2032, covering FDA device user fee changes, CDRH staffing, real-world evidence provisions, fee projections, and preparation steps.

Document NGS bioinformatics pipeline changes, assess validation impact, control software and database updates, and prepare IEC 62304 audit records for IVDs.

Build FDA PCCP drift monitoring protocols for AI imaging devices, including dataset shift, scanner drift, thresholds, cadence, retraining triggers, and submission boundaries.

Design EU MDR PMCF surveys that Notified Bodies accept, with sample frames, CER endpoint mapping, acceptance criteria, statistics, bias controls, and adverse event capture.

Draft QMSR supplier quality agreements for cloud, AI, cybersecurity, testing, and sterilization vendors with audit, CAPA, change notice, and evidence clauses.

Operational guide to converting RUO assays into regulated IVDs, covering claims cleanup, distributor controls, data triage, validation bridging, training, and evidence firewalls.

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.

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.

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.

Track 2026 UDI compliance deadlines across the EU, Switzerland, Australia, China, Brazil, Singapore, and the US, with class rules and data requirements.

Analysis of the 2026 medical device CDMO market, including growth forecasts, major players, M&A trends, outsourcing drivers, and partner selection criteria.

Guide to Switzerland swissdamed mandatory registration from July 1, 2026, covering UDI uploads, Product Module, CH REP duties, M2M, grace periods, and triggers.

Guide to 12 common FDA cybersecurity premarket deficiencies in 2026, including SBOM, threat modeling, risk assessment, Section 524B, guidance alignment, and practical fixes.