LONDON - Physitrack is pleased to announce it has achieved CE marking as a Medical Device (Software) Class I.
This means that Physitrack’s Patient Engagement solution is compliant with the relevant standards and meets the requirements of the Medical Directives put in place by the European Union for the categorisation of software as medical devices.
The Medical Directives outline the safety and performance requirements for medical devices in the European Union and to obtain the marking a detailed suite of risk management documentation is developed along with a structured review of the software development and testing processes to identify and eliminate, or control, risks in the product development and deployment that may affect Physitrack’s healthcare provider customers and their patients.
Physitrack’s Class I CE designation classifies Physitrack’s Patient Engagement solution as a therapeutic tool that does not control or monitor life support systems, enter the body, interrupt physiological processes chemically or dispense medicines.
Obtaining the Class I designation was an onerous task and required demonstrating compliance with a large body of EU industry standards and Medical Directives along with an extensive review of Physitrack’s internal risk management processes for software development, testing, deployment and user experience.
Says Henrik Molin, CEO and co-founder of Physitrack: “CE marking is a formal acknowledgement by regulatory authorities that Physitrack’s solution is developed using a risk management-based approach that ensures that the safety of Physitrack’s users remains our top priority along with cyber security. This is of great importance to our growing Enterprise customer base not only in Europe, but around the world, and we are delighted to have this additional layer of regulatory compliance to demonstrate the robustness of our product and organisation.”
Physitrack is an Apple (NASDAQ: AAPL) Mobility Partner world leader in the provision of Patient Engagement and Telehealth technology to tens of thousands private and public healthcare providers and several million of their patients in over 100 countries.
Frank van Zon, Partner