Risk management and release records for Boost, an unregulated, open-source automated insulin dosing algorithm for AndroidAPS.
Boost is not a medical device with regulatory clearance, and this repository does not make it one. The records here are not a certified quality management system, and no compliance with ISO 13485, ISO 14971 or IEC 62304 is claimed. Nothing here is medical advice.
| Path | What it holds |
|---|---|
hazards/SMB_HAZARDS.md |
Draft hazard log for the SMB dosing action |
evidence/ |
Scripts behind the figures quoted in the hazard logs |
REVIEW.md |
Checks applied before anything is committed here |
The dosing code and the data live elsewhere. No personal data is kept here, and the evidence scripts print counts only and need a local database to run.
The method draws on two published bodies of work, and neither project has reviewed or endorsed this one.
- Tidepool's quality system (https://tidepool.org/open). The severity scale and order of risk controls are adapted from SOP-0006 and TMP-0002. TMP-0002 is licensed CC BY-SA 4.0. Other Tidepool documents are cited as references and are not copied.
- The ELISA Medical Devices working group's STPA of OpenAPS (https://github.com/elisa-tech/wg-medical-devices/tree/main/applying-stpa). The analysis structure follows its method, and its text is not reproduced.
Documents are licensed CC BY-SA 4.0 (see LICENSE), which the material adapted from TMP-0002 requires.