MedDeviceGuide — IVD & Medical Device Knowledge Base

Dedicated CLIA waiver playbook for IVD manufacturers — covering waived, moderate, and high complexity categories, CW submission content, flex studies, lay-user studies, the Dual 510(k) + CLIA Waiver pathway, review timelines, common deficiencies, and real-world examples.

Section-by-section CER template for EU MDR compliance — covering clinical evaluation plan, device description, literature search protocol, data appraisal tables, equivalence justification, benefit-risk analysis, PMCF linkage, evidence traceability matrix, and Notified Body-ready formatting. Free alternative to gated competitor templates.

Practical guide for building a coordinated vulnerability disclosure (CVD) program for medical devices — covering PSIRT setup, vulnerability intake and triage, CVSS scoring, SBOM linkage, field safety notices, FDA Section 524B requirements, EU expectations, and customer communication templates.

Practical guide to using digital twins, synthetic data, and computational modeling in medical device regulatory submissions — covering FDA CM&S credibility guidance, ASME V&V 40, in silico clinical trials, synthetic control arms, model validation pitfalls, and documentation strategies.

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.

Downloadable GSPR checklist template for EU MDR Annex I compliance — covering all 23 requirements across three chapters, with columns for applicability assessment, evidence files, harmonised standards mapping, gap analysis, owner assignment, and remediation tracking. Practical alternative to gated competitor templates.

With EUDAMED becoming mandatory on May 28, 2026, manufacturers are discovering that registration is far more complex than a simple data upload. Here are the 10 most common mistakes — and exactly how to avoid each one.

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.

Complete guide to registering medical devices in Kenya through the Pharmacy and Poisons Board (PPB) in 2026 — including classification (Class A–D), evaluation routes (full, abridged, expedited, immediate), reliance pathways, local authorized representative requirements, import permits, QMS audits, post-market surveillance, and step-by-step registration instructions.

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.

Practical PMCF Plan template aligned with MDCG 2020-7 and EU MDR Annex XIV Part B — covering objectives derivation from CER gaps, method selection (registries, surveys, studies, literature), endpoint definition, sample size logic, schedule, triggers, PMCF evaluation report structure, and PMS integration.

Japan's PMDA made eCTD v4.0 mandatory on April 1, 2026. This guide covers what changed, Japan-specific Module 1 requirements, medical device submission differences, and how to prepare compliant submissions.

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.