Hazard Analysis and ISO 14971 notes

Design Inputs turn user needs and intended use into written product requirements. What they are, how to write them, and a vascular stent example.

Design Outputs are the specifications that make Design Inputs buildable. The types, how they trace to inputs, and the pitfalls that surface at audit.

Design Verification proves the device meets its requirements; Design Validation proves it meets the user need. Sample sizes and the common errors.

Risk management and Hazard Analysis are not parallel activities. They are embedded in design controls, from inputs through the risk management file.

The Design Input and Output Matrix is one table that ties requirements, specifications, verification and risk together. How to build it and keep it current.