MedDeviceGuide — IVD & Medical Device Knowledge Base

How FDA and CDRH staffing reductions may affect 510(k) reviews, pre-submission meetings, MDUFA goals, and regulatory planning for device companies.

Guide to the GLP-1 drug delivery device ecosystem, including auto-injector pens, oral delivery, combination product pathways, FDA, EU MDR, and market outlook.

Analysis of EU MDR and IVDR Notified Body capacity using 2026 survey data, review timelines, certification bottlenecks, IVDR Class C risk, and manufacturer actions.

Guide to FDA's January 2025 draft guidance on AI-enabled device software functions, including TPLC controls, data management, bias mitigation, transparency, and submission content.

Guide to medical device regulatory sandboxes, including MHRA AI Airlock, FDA TEMPO for digital health, EU proposals, eligibility, participation, and market access benefits.

Guide to CSRD sustainability reporting for medical device companies, covering scope, ESRS standards, double materiality, Omnibus simplification, timelines, and practical compliance steps.

How to select, evaluate, and change Notified Bodies under EU MDR and IVDR — capacity constraints, selection criteria, transfer process, 2026 implementing regulation, and timeline planning.

Apply Good Clinical Practice to medical device trials under ISO 14155:2026 and ICH E6(R3), with sponsor duties, consent, safety reporting, and audit readiness.

Independent comparison of regulatory intelligence software for medical device and IVD teams, covering RegDesk, IQVIA, Cortellis, Obsidian, Basil Systems, ArisGlobal, Freyr, and Veeva.

Build cleaning validation protocols for reusable surgical instruments, covering test soils, residue endpoints, worst-case devices, ST98 criteria, sampling, and reports.

Plan a CLIA waiver strategy for IVDs, covering complexity categories, CW content, flex and lay-user studies, Dual 510(k) + CLIA Waiver review, timelines, and deficiencies.

Use a section-by-section EU MDR CER template covering clinical evaluation plans, literature search, appraisal tables, equivalence, benefit-risk, PMCF links, and evidence traceability.

Practical guide to medical device CVD programs, including PSIRT setup, vulnerability intake, CVSS scoring, SBOM linkage, FDA Section 524B, EU expectations, and customer communication.

Practical guide to digital twins, synthetic data, and computational modeling in medical device submissions, covering FDA credibility guidance, ASME V&V 40, validation limits, and documentation.

Guide to regulatory, privacy, and commercial risks for DTC genetic tests, including FDA oversight, FTC claim substantiation, clinical validity, GINA, state privacy laws, and risk-report claims.

Downloadable EU MDR GSPR checklist template for Annex I evidence mapping, applicability, standards, gap analysis, ownership, and remediation tracking.

Learn the 10 most common EUDAMED registration mistakes before the May 28, 2026 mandate, including data, UDI, actor, certificate, and workflow errors, plus fixes.

Regulatory guide for home-use and self-test IVDs, covering FDA OTC and CLIA pathways, EU IVDR self-testing, human factors, labeling, specimen errors, and PMS.

Guide to ISO 17664 reprocessing validation for reusable devices, covering cleaning, disinfection, sterilization, worst-case families, IFU content, FDA expectations, and submission evidence.

Protocol-level guide to IVD analytical validation, covering LoD, LoQ, precision, interference, cross-reactivity, stability, CLSI methods, and FDA/IVDR evidence.