Policy on Healthware Safety

Distributed manufacturing can serve as a powerful mechanism for delivering health-related hardware to communities precisely when and where it is needed.

In a time where access to care becomes increasingly debated, restricted, and prevented, openly sharing health devices is imperative to healthy communities.

While delivering health-related hardware to communities is an important driver of the Open Healthware project, it is also critically important to ensure that medical devices are both readily accessible and reproducible. OSHWA’s response to this need is the development of a standardized process for open source health and medical devices, referred to as the Open Healthware Certification. This certification indicates that a project contains all source materials required for Open Healthware source and expands upon the existing OSHWA certification by incorporating additional elements that strengthen transparency, reproducibility and documentation.

The Open Healthware Certification does not guarantee the safety of any certified project; final assessments of safety and use remain the responsibility of the producer, user, and relevant regulatory authorities within each country.

Start learning about Open Healthware