IEC 62366: Usability Engineering Process, File and Evidence
IEC 62366 is built on one uncomfortable idea: a patient can be seriously harmed while every component of the device performs exactly as specified. The…
MD Regulatory Blog
Risk Management
Risk Management
-
-
ISO 24971 for IVDs: Risk Management When the Harm Is Indirect
ISO 24971 is the document that explains how to do what ISO 14971 requires, and for in vitro diagnostic medical devices it carries something the…
-
Medical Device Cybersecurity Risk Assessment: Threat Modeling and FDA Requirements
A medical device cybersecurity risk assessment is no longer a documentation exercise that supports a submission — it is now a condition of market access.…
-
ISO 14971 Risk Management for Medical Devices: Complete Process Guide
ISO 14971 is the foundational international standard for risk management of medical devices. It specifies terminology, principles, and a comprehensive process for risk management of…
-
The Benefit-Risk Analysis: Avoid Critical Mistakes and Achieve Full Compliance
The benefit-risk determination is the conclusion the whole technical file exists to support. Every risk control, every clinical study, every piece of post-market data feeds…
