Ensho Health today announced that the company received ISO 13485:2016 certification for Medical Device and Quality Management Systems from DEKRA. The ISO certification indicates that Ensho's quality management system meets the most current regulatory requirements specific to developing cloud-based software that screens electronic medical record data to aid in the diagnosis of rare diseases.
"This certificate demonstrates our commitment to quality and developing safe, secure and effective medical device software that empower healthcare providers to improve patient outcomes" said Kaveh Katebian, Ensho Health Co-Founder and Chief Executive Officer.
ISO 13485:2016 is an internationally recognized quality standard for a quality system to ensure customer and regulatory requirements are consistently met throughout the lifecycles of medical device products. "This certification is a testament to efforts of our team in establishing a rigorous and risk-based approach to developing and deploying medical device software that can transform screening for rare and complex diseases" said Kevin Ballard, Ensho Health Chief Technology Officer.
About Ensho Health
Ensho Health is a health technology company that empowers physicians to do more with data. It provides software-enabled services for clinical research, quality improvement and accredited learning. Healthcare providers use its systems and services to match patients with clinical trials, enrol data in registry studies, assess guideline adherence rates, improve quality of programs and participate in self-reflective exercises including those accredited by oversight bodies.
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