Projects / P-11
Medical devices
Fixing a rejected design dossier
Revising the design file for a long-term implantable central venous catheter after it had been rejected at review.
P-112025
- Project
- Risk analysis for a long-term implantable catheter
- Context
- MSc, University of Sheffield
Class IIIhighest-risk device class
120 daysin contact with the bloodstream
6people in the team
The question
What needed to change for this catheter's design file to stand up to review?
What I did
- Owned the risk management section: wrote the risk management plan and the FMEA, including risk controls and residual risk scoring.
- Reviewed the biological evaluation, checking that the biocompatibility tests matched a device in long-term contact with circulating blood.
- Checked the wider technical file for consistency with the risk file.