Clinical Evidence
34 articles
Patient-Reported Outcomes in Medical Device Trials: PRO Instruments, Validation, and FDA/EU Expectations
Guide to selecting, validating, and using patient-reported outcome (PRO) instruments in medical device clinical trials — FDA CDRH draft guidance on fit-for-purpose PROs, EU MDR clinical evaluation requirements, COA types (PRO, ClinRO, ObsRO, PerfO), instrument validation, endpoint hierarchy, and regulatory submission strategies.
Sample Size Calculation for Medical Device Clinical Investigations: Practical Methods and Examples
Practical guide to sample size calculation and justification for medical device clinical investigations — ISO 14155:2026 requirements, EU MDR Annex XV expectations, FDA IDE statistical guidance, superiority vs non-inferiority vs equivalence designs, Bayesian approaches, adaptive sample size re-estimation, pilot study sizing, and worked examples for orthopedic, cardiovascular, and diagnostic accuracy studies.
State of the Art Review for Medical Devices: SOTA Methods, Comparator Selection, and CER Examples
Complete guide to conducting a state of the art (SOTA) review for medical device clinical evaluation under EU MDR — regulatory definitions, SOTA methodology, comparator and benchmark device selection, clinical outcome parameters, MDCG 2020-6 evidence hierarchy, and practical examples for building a defensible CER.
Statistical Analysis Plan for Medical Device Trials: Endpoints, Estimands, Missing Data, and Sensitivity Analyses
Comprehensive guide to developing a Statistical Analysis Plan (SAP) for medical device clinical trials — ICH E9 and E9(R1) estimand framework, primary and secondary endpoint hierarchy, analysis populations (ITT, PP, safety), missing data strategies (MI, tipping-point), sensitivity and supplementary analyses, multiplicity adjustment, SAP timing and approval, and regulatory expectations from FDA, EMA, and EU MDR for device submissions.
Humanitarian Device Exemption (HDE): Complete Guide to FDA Rare Disease Device Pathway
Comprehensive guide to the FDA Humanitarian Device Exemption (HDE) pathway for rare disease medical devices — HUD designation process, HDE application requirements, probable benefit standard, profit restrictions, IRB oversight, post-approval obligations, QMSR implications, and step-by-step instructions.
ISO 14155:2026 Clinical Investigation of Medical Devices — Complete GCP Guide
A comprehensive guide to ISO 14155:2026 for medical device clinical investigations — the 4th edition's risk management integration, Clinical Events Committees, estimand framework, sponsor and investigator responsibilities, adverse event reporting, and post-market study requirements.
PSUR Under EU MDR Article 86: Complete Periodic Safety Update Report Guide with 2026 EUDAMED Requirements
How to prepare, structure, and submit a compliant PSUR under MDR Article 86 — frequency by device class, MDCG 2022-21 template walkthrough, EUDAMED submission for Class III and implantables, benefit-risk analysis, PMS data integration, and the 2025 simplification proposal that may change reporting cadence.
EU MDR Summary of Safety and Clinical Performance (SSCP): Complete Guide for Class III and Implantable Devices
How to prepare, validate, and publish the Summary of Safety and Clinical Performance (SSCP) under EU MDR Article 32 — MDCG 2019-9 Rev.1 template walkthrough, HCP and layperson sections, readability testing, Notified Body validation process, translation requirements, EUDAMED upload timelines, and common NB findings in 2026.
MENA Medical Device Clinical Investigation & Trials: Regulatory Requirements by Country
Complete guide to medical device clinical trial requirements across MENA — Saudi SFDA MDS-REQ-2 clinical trial framework (295 studies evaluated, 157 approved), UAE clinical investigation pathways, Egypt EDA Clinical Trials Law 214/2020 with three authorization pathways, Turkey TITCK Regulation on Clinical Trials, Israel MOH oversight, Qatar Law 6/2025, and practical strategies for multi-country trial management.
Real-World Evidence (RWE) for Medical Devices (2026): FDA Guidance, Data Sources, Regulatory Uses & Implementation Guide
Everything you need to know about using real-world evidence (RWE) and real-world data (RWD) for medical device regulatory submissions in 2026 — including the December 2025 FDA final guidance update, acceptable data sources (EHRs, registries, claims databases), relevance and reliability criteria, premarket and postmarket applications, de-identified data policy change, practical steps for incorporating RWE into your regulatory strategy, and comparison with traditional clinical evidence.
PMA Submission Cost: Complete 2026 Budget Breakdown for Class III Devices
A comprehensive cost breakdown for FDA Premarket Approval (PMA) submissions — covering user fees, clinical trials, consulting, testing, and post-market obligations — with FY 2026-specific figures for Class III medical device manufacturers.
Medical Device Clinical Trials: Complete Guide to FDA IDE Requirements, 21 CFR 812, and Investigational Studies
The complete guide to medical device clinical trials — FDA IDE requirements under 21 CFR 812, significant risk vs non-significant risk classification, IDE application process, study design, ISO 14155, costs, timelines, and practical strategies for regulatory professionals.
Post-Market Clinical Follow-Up (PMCF) Under EU MDR: Plans, Studies, and the Complete Implementation Guide
A comprehensive guide to PMCF under EU MDR — covering PMCF plan development, study design, evaluation reports, integration with PMS and clinical evaluation, and practical implementation strategies.
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.