Before a device is released, ISO 14971 §10 and ISO 13485 §8.2.1 ask you to decide how you will find out whether its risk file is still true once it is in use. This interview writes that plan for one device, one question per screen:
- Scope — the device, the risk file the plan keeps true, where it is sold, and how many are in use.
- Collect — which of the six kinds of information ISO 14971 §10.2 names you will gather, and who looks at each.
- Watch — the risks to watch most closely, and the limit that would mean the risk file is wrong.
- Act — what happens when a limit is crossed — the risk file is always flagged and updated.
- Own — how often everything is reviewed, and who runs the plan.
The plan keeps the risk file of a fictional blood glucose meter true — RA-001, with 4 risk items — and three fictional people can be named as owners.
The screens on this page are Indelio’s own post-market surveillance plan interview — the same component the product uses — given a fictional glucose meter, its risk file and three fictional people instead of your records. The review screen lists what approval would still refuse on, exactly as in the product. In Indelio the plan is saved as its own record and approved with an electronic signature by someone other than its author; this page keeps it only while it is open. The plan covers ISO 14971 §10 and ISO 13485 §8.2.1; it is not an EU MDR post-market surveillance plan or a periodic safety update report.