How to write excellent Design Input?

Clear Design Inputs are vital in medical device development under ISO 13485 or FDA regulations. Use the CUVC framework:

• Complete: Cover all aspects.

• Unambiguous: Avoid vague terms; use "shall."

• Verifiable: Specify testing methods.

• Consistent: Ensure no contradictions.

For example, instead of "The pump should deliver medication," say, "The infusion pump shall deliver at rates between 0.1 mL/hr and 999 mL/hr."

Tools like Matrix Req simplify management by centralizing requirements and validation, ensuring clarity and traceability throughout development.