OSHWA Issues First Open Healthware Certifications for Open-Source Medical Devices

# What happened

# Why it matters

A separate certification pathway signals that OSHWA is treating health-related hardware with its own criteria and workflows. That matters because medical and clinical use cases carry different safety, regulatory, and documentation expectations than general open hardware. A dedicated track helps creators document design, software, and use parameters in ways more relevant to clinicians, researchers, and institutional adopters.

# What's certified so far

The public Open Healthware Certification database lists four individual certifications. The announcement highlights three projects by name and describes their scope and intended use:

• Universal Mounting System (IUD KE0000001): A set of 3D-printed attachments designed for hospital environments. The system is modular: a back piece mounts to walls, beds, trolleys, and poles, while interchangeable front pieces hold items such as humidifier bottles and handheld pulse oximeters. The parts are mutually compatible and intended to expand use cases in clinical settings.

• COSMIIC (IUD US00002851): A fully implantable neuromodulation platform that was released with NIH SPARC funding. COSMIIC supports research into spinal cord injury and other neural applications and has been shared across multiple research projects.

OSHWA noted that projects certified through the Healthware process will also appear in the association's general certification database.

# How the community can engage

Creators can submit projects for Open Healthware certification through OSHWA's usual certification channels. OSHWA invites submissions and has promoted ways to follow new certifications, including a Mastodon certification bot. The announcement also referenced deeper conversations with project leads via the community program Show & Tell Monthly.

# Practical implications for developers and researchers

• If you design open health hardware, expect a certification pathway that foregrounds clinical and research-relevant documentation.
• Certified projects stay discoverable in OSHWA's main database, so certification increases visibility within both open-hardware and health-focused communities.

# Short next steps

If you have an open health device or are researching one: review OSHWA's certification pages, prepare documentation focused on clinical use and safety context, and consider submitting your project for Open Healthware certification to appear in both the healthware and general databases.