EU market
EU MDR
Articles on MDR strategy, classification, technical documentation, clinical evaluation, PMCF, and Notified Body readiness.
Discuss EU MDRRegulatory intelligence
Focused writing on market access, evidence, and compliance systems
Each topic below maps to the regulatory labels in the Pionus globe. The blog structure separates EU MDR and US FDA market access while keeping cross-cutting topics such as cybersecurity, usability, clinical evaluation, and clinical studies visible.
Market access
EU and US pathways
US market
US FDA market access
Articles on FDA QMSR, 510(k), De Novo, PMA, pre-submission strategy, and evidence planning for US launch.
Discuss FDA market accessQuality and product systems
Standards behind robust execution
US quality system
FDA QMSR
FDA Quality Management System Regulation, ISO 13485 alignment, design controls, and inspection readiness.
US market pathway
FDA 510(k)
Predicate strategy, substantial equivalence, test planning, and submission evidence for 510(k) clearance.
US market pathway
FDA De Novo
Novel device classification, benefit-risk framing, special controls, and evidence planning for De Novo requests.
US market pathway
FDA PMA
Premarket approval strategy, clinical evidence expectations, manufacturing controls, and advisory readiness.
Quality
DIN EN ISO 13485
Quality management systems, design controls, supplier controls, CAPA, and audit readiness.
Risk
ISO 14971
Risk management files, benefit-risk logic, residual risk, and risk-control traceability.
Software lifecycle
DIN EN IEC 62304
Software safety classes, lifecycle documentation, SOUP, verification, and maintenance processes.
Electronic records
21 CFR Part 11
Audit trails, electronic signatures, validation, access control, and compliant records workflows.
Special topics
Cybersecurity, usability, and clinical evidence
Cybersecurity
FD&C 524B
US cybersecurity expectations, secure product development, SBOM, vulnerability handling, and postmarket duties.
Health software security
IEC 81001-5-1
Security activities for health software, threat modeling, architecture controls, and lifecycle evidence.
Usability
IEC 62366
Use-related risk, formative studies, summative validation, and human factors documentation.
Clinical evaluation
MDR CER
Clinical evaluation plans and reports, equivalence, literature strategy, state of the art, and PMCF integration.
Clinical investigation
ISO 14155
Clinical investigation planning, protocol quality, monitoring, ethics, and study documentation.
Clinical studies
ICH E6 GCP
Good Clinical Practice, sponsor responsibilities, quality by design, study oversight, and data integrity.