Tag: human factors usability

Device Malfunctions & MDR Reporting: A Regulator-Ready Playbook for Fast, Defensible Vigilance (2025)

November 3, 2025 digi

Device Malfunctions & MDR Reporting: A Regulator-Ready Playbook for Fast, Defensible Vigilance (2025) Engineering Device Malfunction Handling and MDR Reporting That Withstand Inspection Purpose, Definitions, and the Global Compliance Frame Device vigilance is different from drug safety. A single malfunction—even without injury—may be reportable if recurrence could cause serious harm. Getting these calls right requires…

Adverse Event Reporting & SAE Management, Device Malfunctions & MDR Reporting

Device & Diagnostic Transparency: A Regulator-Ready Blueprint for Clinical Investigations and Performance Studies (2025)

October 28, 2025 digi

Device & Diagnostic Transparency: A Regulator-Ready Blueprint for Clinical Investigations and Performance Studies (2025) Delivering Transparency for Medical Devices and Diagnostics—Clear, Coherent, and Inspection-Ready Why Device & Diagnostic Transparency Matters—and the Global Anchors That Shape It Transparency for devices and diagnostics is different from drug disclosure, but the intent is the same: respect participants, enable…

Clinical Trial Transparency & Disclosure, Device & Diagnostic Transparency

Device & Combination Product Regulations: A Global Playbook for Pathways, Quality, and Clinical Evidence

October 21, 2025 digi

Device & Combination Product Regulations: A Global Playbook for Pathways, Quality, and Clinical Evidence Designing, Investigating, and Registering Devices & Drug–Device Combinations Across Major Regulators The Global Device Rulebook: How Pathways and PMOA Drive Your Plan Medical devices and drug–device combinations live in a different regulatory universe than pure pharmaceuticals, but the strategic goal is…

Device & Combination Product Regulations, Regulatory Frameworks & Global Guidelines