OSHWA developed the Open Healthware Certification to address the unique challenges and responsibilities associated with health and medical technologies. OSHWA has also produced a number of guides for those seeking to create Open Healthware. The guides assume general technical competence but does not assume formal training in medical device regulatory processes or quality systems.
Best Practices for Releasing Open Healthware Designs is intended for individuals who are looking to publish open-source health hardware or Open Healthware. The goal of this document is to support transparent, and responsible publication of open healthware designs. It focuses on what information should be communicated publicly in addition to what is listed in the definition of open hardware, so that others can understand a device’s design, assembly, and validation, along with metadata like intent, limitations, risks, appropriate contexts for use. This guide is not a substitute for regulatory compliance documentation and does not certify devices for clinical use. Each section highlights a class of information that should be documented when publishing source for an open healthware project. This guide seeks to answer the question “what are the best practices around the documentation my open healthware project should have”, not with an exhaustive list, but with some of the factors that the healthware community has raised.
Best Practices for Contributing to Open Healthware Designs is intended for individuals who are looking to contribute to existing Open Healthware projects. It assumes general technical competence but does not assume formal training in medical device regulatory processes or quality systems. The goal of this document is to support community engagement and foster productive collaboration over open healthware designs. It focuses on what contributors should be aware of when engaging with Open Healthware projects. This guide is not a substitute for regulatory compliance documentation and does not certify devices for clinical use.
Best Practices for Replicating Open Healthware Designs is intended for individuals who are looking to replicate Open Healthware. The goal of this document is to aid reproducers of open healthware in making best use of available documentation. It focuses on what relevant information might be communicated publicly including metadata like intent, limitations, risks, appropriate contexts for use. This guide is not a substitute for regulatory compliance documentation and does not certify devices for clinical use. This guide seeks to answer the question “what are the best practices I should consider if I decide to reproduce an open healthware project”.
Best Practices for Open Healthware Device Quality was designed for reproducers and manufacturers of Open Healthware. It has material for users and designers of Open Healthware related to device quality practices. The goal of this guide is to suggest practices that can be utilized by reproducers, designers, and users of Open Healthware to achieve the highest quality reproduction of an Open Healthware project. For best use of this guide, we recommend taking the information provided here as a starting point and doing further research on the topics covered in this guide, as necessary.