SAN DIEGO – December 11, 2018 – Reflexion Health, a digital therapeutics company focused on virtual physical therapy, announced today that it has been awarded International Organization for Standardization (ISO) 13485:2016 certification for medical device quality management systems. Reflexion Health’s technology platform VERA™ is a patient-centered, data-driven, and value-based digital platform that combines avatar coaching and 3D biometrics with tools that enable clinicians to remotely monitor patients beyond the traditional in-clinic setting.
“The receipt of this certification underscores our efforts to maintain the highest standard of quality, safety and effectiveness in our operations,” said Walter Cordiglia, Reflexion Health’s chief compliance officer. “Quality is the foundation of everything that we do at Reflexion Health, and with this certification, physicians and patients can have confidence that VERA is built using consistent design, development, production, installation, and delivery processes that not only meet but exceed the highest safety standards.”
ISO is an independent, non-governmental international organization with a membership of 162 national standards bodies based in Geneva, Switzerland. ISO 13485:2016 is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Earlier this year, the US Food and Drug Administration (FDA), which regulates the medical devices sector, announced its intention to use ISO 13485 as the basis for its quality system legislation, further validating the significance of this standardization.
“We believe strongly that evidence is paramount to our success as a company,” said Joseph (Joe) Smith, M.D., Ph.D., Reflexion Health’s CEO. “Although not required, and often deprioritized by other industry participants, we believe that obtaining such validation is the right thing to do on behalf of patients and providers when delivering new health technologies. Reflexion Health is proud to achieve this certification that is highly recognized by the FDA, and serves as an international benchmark of quality.”
VERA is uniquely designed to deliver home-based, on-demand therapy sessions. The platform’s engaging avatar – combined with remote monitoring, 3D motion-capture technology and telehealth visits – enables patients to recover comfortably, conveniently and confidently at home, saving them from the burden of finding rides, dealing with traffic or making appointments. In addition, the provider-facing dashboard, complete with an industry-leading collection of relevant paient data, enables remote, clinical oversight.
For more information on Reflexion Health, please visit www.reflexionhealth.com.
About Reflexion Health
Reflexion Health is a virtual rehabilitation therapy company dedicated to bringing patients evidence-based technology that helps them recover at home. VERA™, Reflexion Health's lead product, is an FDA-cleared Virtual Exercise Rehabilitation Assistant that is able to support and remotely monitor physical therapy exercises in real-time. VERA brings the guidance of a physical therapist into the home to coach, motivate and assess exercise movements adherence to prescribed physical therapy recovery exercises. Reflexion Health is owned by Digital Health Corp, a diversified healthcare company. For more information, please visit www.reflexionhealth.com.
Reflexion Health Communications Contact:
VP Canale Communications