Connected Health Companies
Building powerful SaMD and connected device systems.
Software as a medical device (SaMD) offers many key benefits, often improving patient outcomes by being directly used in the treatment of an individual.
Connected Health companies know that any product they develop which has the potential to impact patient safety, needs to meet specific regulatory requirements.
OdysseyVC’s CompliantCloud can support connected health companies in demonstrating that their SaMD has been built and documented with compliance and safety in mind. Let CompliantCloud be an essential tool that supports your quality management processes.
For Connected Health companies to be successful they must have an awareness of how the regulations influence SaMD development activities. Failure to understand the unique requirements that are driven by the regulations and ultimately patient safety creates a significant barrier to success. OdysseyVC acutely understands the industry regulatory requirements and what is needed to support Connected Health companies in their use of Cloud technology.
Ensuring that your SaMD meet regulatory expectations starts with ensuring that your foundational infrastructure is qualified and fit for purpose. The experts at OdysseyVC have developed a fully qualified infrastructural platform that supports connected health IoT companies. The platform has been designed in accordance with industry regulations and guidelines such as FDA 21 CFR Part 11 and EMA Annex 11 and supports the internationally agreed standard (ISO 13485) that sets out quality management system requirements specific to the medical devices industry.
A vendor you can trust
OdysseyVC is acutely aware of the criticality of vendor selection for Connected Health companies. As an experienced and seasoned service supplier to life sciences, OdysseyVC know that to be a successful vendor you must replicate industry best practices.
We understand that although we are not directly responsible for the SaMD solution compliance status, our regulated customer will rely heavily on our activities and process to support demonstration of compliance. That is why we have put in place procedures and governance that supports regulated activity