Biocompatibility Risk Assessment for Catheter Material Change
| University | South East Technological University (SETU) |
| Subject | Regulatory Affairs Quality Management and Strategy |
Assignment part 1
A manufacturer decides to change the material of a catheter from polymer A to polymer B. Material B is used in another of the manufacturer’s own cleared catheters, which has the same type and duration of patient contact, as well as the same performance specifications. Both polymers A and B are molded materials and are sterilized by ethylene oxide.
Polymer B, as polymer A will be in contact with body tissues or fluids, directly or indirectly. Due to a different chemical formulation for polymer B, the risk assessment identifies that the new formulation presents a new biocompatibility risk.
Are You Searching Answer of this Question? Request Ireland Writers to Write a plagiarism Free Copy for You.
Task
Outline and explain the steps you would take in order to assess the risk related to this change. Plan, implement, and document this change in compliance with FDA QSR (21 CFR Part 820) regulations and ISO 13485:2016.
