Attribution 4.0 International (CC BY 4.0) Contribute on GitHub Download PDF Download PDF

Stakeholder Needs

The Docs-as-Code for Open-Source Medical Hardware & PPE’s architecture is guided by a series of stakeholder needs, listed below.

1: Quality System Processes for Medical Device Manufacturers

Manufacturers of medical devices shall ensure that finished devices will be safe and effective.[1][2]

Data Structures

This section covers each data structure type in the Docs-as-Code for Open-Source Medical Hardware & PPE’s architecture.

1. 21 CFR Part 820 — Quality System Regulation https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820
2. ISO 13485 - Quality Management for Medical Devices https://www.iso.org/iso-13485-medical-devices.html