VERA, a virtual physical therapy platform designed to enable clinicians to remotely monitor patients outside the clinic, has been awarded International Organization for Standardization (ISO) 13485:2016 certification for medical device quality management systems, according to Reflexion Health.
VERA features a combination of 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,” says Walter Cordiglia, Reflexion Health’s chief compliance officer, in a media release.
“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), the government department that 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, the release continues.
“We believe strongly that evidence is paramount to our success as a company,” states Joseph (Joe) Smith, MD, PhD, Reflexion Health’s CEO. “Although not required, and often not prioritized 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.”
[Source(s): Reflexion Health, PR Newswire]
