The Internet-of-Things (IoT), single purpose device connected to the internet, is revolutionizing the health care industry. To ensure system quality, your one-of-a-kind medical device needs to connect to a FDA compliant cloud that offers full design controls and formal testing capabilities.
Tietronix is a Galen Data partner. Galen Data is an FDA/HIPAA compliant platform that allows medical device companies to connect to the cloud in a fraction of the time and cost it takes currently. It allows the companies to leverage their device data to create better devices and outcomes. The platform supports FDA Class I, II, III and CE marked medical devices. Build under ISO 13485 compliant Quality Management System the platform meets or exceeds design control requirements for both US and global markets. Security is actively managed, and tools to comply with data privacy regulations are provided. Built in widgets allow intuitive presentation of data to Clinicians, Patients or their family. Galen Cloud is configurable, isolating the data you want and presenting it in a way that works for you. Galen Cloud is available as a managed infrastructure, so you can focus on your device innovation. Using Galen Cloud, you can reduce the time and cost to market compared to a custom solution.
For project inquiries please visit www.galendata.com