Clinical Evidence
50 articles
Humanitarian Device Exemption (HDE): Complete Guide to FDA Rare Disease Device Pathway
Use FDA's HDE pathway for rare disease devices, including HUD designation, probable benefit evidence, HDE applications, profit rules, IRB oversight, QMSR, and post-approval duties.
ISO 14155:2026 Clinical Investigation of Medical Devices: GCP Guide
Guide to ISO 14155:2026 for medical device clinical investigations, covering GCP expectations, risk management, committees, estimands, sponsor duties, adverse events, and post-market studies.
PSUR Under EU MDR Article 86: 2026 Periodic Safety Update Report Guide
Prepare an EU MDR Article 86 PSUR with class-based frequency, MDCG 2022-21 structure, EUDAMED submission, PMS data, and benefit-risk analysis.
EU MDR SSCP Guide: Safety and Clinical Performance Summary for Devices
Learn how to prepare, validate, translate, and publish EU MDR SSCPs under Article 32, including MDCG 2019-9 Rev.1, lay summaries, NB review, and EUDAMED.
MENA Medical Device Clinical Investigation & Trials: Regulatory Requirements by Country
Compare MENA medical device clinical trial requirements, including Saudi SFDA, UAE, Egypt, Turkey, Israel, Qatar, authorization routes, evidence expectations, and multi-country trial planning.
Real-World Evidence for Medical Devices: FDA RWE Guidance and Regulatory Uses
Guide to using real-world evidence and real-world data in medical device submissions, including FDA guidance, data sources, reliability criteria, and regulatory strategy.
PMA Submission Cost: Complete 2026 Budget Breakdown for Class III Devices
Budget FDA PMA submissions for Class III devices with FY 2026 user fees, clinical trial costs, testing, consulting, post-market obligations, and planning benchmarks.
Medical Device Clinical Trials: FDA IDE Requirements Guide
Understand FDA IDE requirements, 21 CFR 812 risk categories, study design, ISO 14155 alignment, submission steps, costs, and clinical trial timelines.
EU MDR PMCF Guide: Plans, Studies, Reports, and Implementation
Guide to PMCF under EU MDR, including PMCF plans, study design, evaluation reports, PMS integration, clinical evaluation updates, and implementation.
Clinical Evaluation Report (CER) for Medical Devices: The Complete Guide
How to write a Clinical Evaluation Report that meets EU MDR requirements and passes Notified Body review — methodology, structure, literature search strategy, and common pitfalls.