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Openwater Safety Data

Sharing Safety Data massively reduces regulatory approval costs and makes a safer product. Openwater is providing a way to pool safety data to lower the number of patients needed for a clinical trial or a regulatory approval.

Openwater is providing a way to pool safety data to lower the number of patients needed for a clinical trial or a regulatory
Sharing safety data at Openwater

Advancing Healthcare through Collaborative Safety Data Sharing in Medical Component
Development

Openwater is enabling collaboration and sharing of safety data to reduce cost and speed rapid development and regulatory approval of new technologies. In the ever-evolving landscape of medical component development, manufacturers, developers, and researchers stand to gain substantial benefits from the proactive sharing of safety data pertaining to components in development. This collaborative approach not only fosters a culture of transparency and innovation but also yields numerous advantages in terms of regulatory compliance, cost savings, and the ability to leverage safety data across multiple clinical trials.

Key Advantages

The benefits of collaborative safety data sharing in medical component development extend far beyond individual companies or researchers. By fostering an environment of openness, transparency, and shared learning, stakeholders collectively contribute to advancing healthcare, ensuring patient safety, and driving innovation in the dynamic field of medical device development. Join us in leading innovation. For more information contact safety@openwater.cc

How to Participate in Safety Sharing

Safety Disclosure


This notification serves as a safety disclosure for the our Open-LIFU and Open-Motion, medical components intended exclusively for research purposes. Openwater acknowledges that, as of January, 2024 the device has not undergone review and clearance or approval by the U.S. Food and Drug Administration (FDA) for commercial distribution and use.

Important Safety Information

Openwater Safety Monitoring Template

Monthly submission to safety@openwater.cc sample below

Please register your work with safety@openwater.cc for more tools to ease submissions burden.

Join Us!

Email us at safety@openwater.cc

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