Confirm what the report must prove
Start from controlled requirements and the applicable standard clauses. A laboratory slot should not be the first time the team agrees on configuration or acceptance criteria.
- Applicable editions, collateral standards, and national deviations are confirmed
- Test units represent the intended submission configuration
- Accessories, software, labeling, and operating modes are controlled
- Methods and acceptance criteria trace to requirements
- Known anomalies and risk controls are disclosed
Plan for failures and changes
Reserve time for investigation, corrective design work, and regression testing. Agree in advance how deviations, interim data, photos, raw observations, and final reports will be handled.