MedDeviceGuide — IVD & Medical Device Knowledge Base

Clear guide to ISO 14971 risk management files and reports, including required contents, traceability expectations, document structure, and audit findings.

Guide to classifying SaMD, SiMD, and embedded medical device software, with IMDRF definitions, IEC 62304 risk classes, FDA and EU MDR pathways, and documentation strategy.

Practical guide to sample size justification for device clinical investigations, covering ISO 14155, EU MDR Annex XV, FDA IDE expectations, common study designs, and worked examples.

Compare Singapore Registrant pricing models for HSA medical device registration, including hourly, annual, and flat-fee options with 3-year cash flow examples.

Build a defensible SOTA review for EU MDR clinical evaluation, with comparator selection, benchmark devices, outcome parameters, MDCG evidence hierarchy, and CER examples.

Develop a medical device SAP covering endpoints, estimands, analysis populations, missing data, sensitivity analyses, multiplicity, timing, and FDA/EU MDR expectations.

Guide to Sunshine Act and Open Payments compliance for device manufacturers, including covered recipients, reportable payments, 2026 thresholds, CMS submissions, penalties, and audits.

Compare Swiss CH-REP pricing models for 2026, including Pure Global flat fees, hourly billing, registration-plus-annual fees, and 3-year cash flow scenarios.

Thailand medical device registration cost guide for 2026, comparing Thai License Holder pricing, flat-fee options, and 3-year cash flow by device class.

UK medical device registration cost guide for 2026, comparing UKRP hourly, annual, and flat-fee pricing with 3-year cash flow and MHRA fee impacts.

Compare U.S. Agent and Official Correspondent pricing models, FDA annual fees and 3-year cash flow scenarios for foreign device manufacturers in 2026.

Learn how to translate VOC and user needs into verifiable design inputs with FDA QMSR, ISO 13485, traceability examples and audit-ready documentation.

Buyer-side guide to Vietnam AR/MAH service pricing, flat fees versus hourly billing, and 3-year cash flow scenarios for Class A-D registrations.

Guide to EAEU medical device registration, comparing national and union pathways, classification, fees, representatives, clinical evidence, and 2027/2028 transition deadlines.

Practical GDPR guide for device and IVD manufacturers, covering health data, DPIAs, DPO duties, lawful bases, transfers, EU MDR, IVDR, and AI Act overlap.

Use generative AI in device regulatory work with governance for submissions, literature review, intelligence, clinical evaluation, GxP controls, and compliance risks.

Build a medical device go-to-market plan covering regulatory-commercial alignment, hospital procurement, value analysis, sales channels, pricing, and launch timelines.

Guide to medical device product liability and insurance, including strict liability, negligence, coverage types, EU 2024/2853 changes, recalls, and risk controls.

Guide to managing SOUP under IEC 62304, covering identification, risk assessment, safety classification, documentation, open-source controls, and post-market monitoring.

Guide to medical device environmental compliance covering EU RoHS restricted substances, REACH SVHC and SCIP duties, WEEE producer obligations, global RoHS rules, and 2026 strategy.