- Impacted products and markets
- Device classification
- Impact to:
- Essential Requirements Checklist
- List of Standards
- Risk Analysis
- Product Label and Instructions for Use
- Biocompatability
- Shelf Life
- Product Specification
- Clinical Evaluation
- Product design changes: the change would affect conformity with
- Changes to the quality system:
- NB-MED/2.5.2/Rec2 Reporting of design changes and changes of the quality system http://team-nb.org/documents/2011/Approved_NB-MED_2_5_2_rec_2_november_2008.pdf