Connected Health Companies

Building powerful SaMD and connected device systems.

Overview

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.

The Platform

Full Visibility.
Full Control.

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.

Opportunities

Reduce cost and time associated with qualifying cloud infrastructure by leveraging an established and controlled solution
Increase confidence in your outsourced infrastructure by having the transparency and evidence to support regulatory inspections
Gain market access and competitive edge by demonstrating your SaaS environment meets industry regulations
Increase your ability to focus on your core business by automating mandatory compliance deliverables

The Company

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

Always driving compliance excellence

Quality Management System (QMS)

OdysseyVC has implemented a robust Quality Management System and has been awarded ISO 9001 certification. By maintaining a defined and transparent quality process, we can comfortably demonstrate our platform’s qualification process and controls for development, change, configuration and security.

Information Security Management System (ISMS)

OdysseyVC proactively manages its security responsibilities, supported by an effective and sustainable Information Security Management System (ISMS). We are ISO 27001 certified. This ISO 27001 certification demonstrates our commitment to keeping high standards of security and consistent service.

Audit Ready

Having truly understood what is necessary to be a supplier to life sciences, OdysseyVC can effectively and efficiently support regulatory inspections and audits and confidently demonstrate that our platform and business is fit for purpose.