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Flex Digital Health, Inc. Achieves ISO 13485:2016 Quality Certification

Flex Digital Health, Inc. Achieves ISO 13485:2016 Quality Certification

Flex Digital Health, Inc. has been awarded the International Organization for Standardization (ISO) 13485:2016 certification for medical device quality management systems.

Flex Digital Health’s core product offering, BrightInsight, is a medical-grade, intelligent platform that optimizes connected drug, device and combination products through real-time, integrated data and actionable insights to enable customers to drive increased patient adherence and engagement. Deployed as a managed service, BrightInsight is designed to support CE-marked and FDA-regulated Class I, II and III medical device, combination product and Software as a Medical Device requirement.

This ISO certification is another milestone for Flex Digital Health following the acceptance of its master file by the FDA for the BrightInsight Platform in March of 2018.

More about Flex Digital Health’s ISO 13485:2016 certification:

  • This certification demonstrates to Flex Digital Health’s customers that the company operates a cutting-edge quality management system for software development services, such as developing and hosting Software as a Medical Device.
  • To achieve certification, Flex Digital Health’s processes, documentation and quality culture were audited independently in accordance with ISO 13485:2016 standard.
  • The certification builds on the FDA’s quality system regulations principles and is recognized internationally.
  • The ISO certification demonstrates that Flex Digital Health’s medical-grade BrightInsight platform was built with the highest Quality Management System
  • Flex Digital Health’s Agile software development process was also part of the certification — critical in proving the company meets the stringent requirements of ISO 13485:2016 while continually improving its BrightInsight software.
  • ISO is an independent, non-governmental international organization with a membership of 162 national standards bodies based in Geneva, Switzerland.
  • 13485:2016 is the latest update to the ISO criteria maintained for effective quality management system practices, previously revised in 2003. This long-awaited revision expands risk management, adds new safeguards, and outlines new policies for quality control in supply chain management.

 

“Flex Digital Health is committed to providing medical-grade solutions for our pharma and medtech customers who operate in highly regulated industries, and our ISO 13485:2016 certification is another affirmation of this commitment. said Michael Righter, Senior Director, Regulatory Affairs at Flex Digital Health.

The Digital Health Maturity Curve

  1. Digital-savvy pharma and medtech companies are adding new regulated digital health capabilities – such as controlling connected devices, drug dosing, decision support and automated interventions -- as a way to improve patient engagement, deliver actionable insights to providers, and provide more value around their products and therapies.

    As companies transition from developing simple companion apps, to capturing data from connected medical devices, to building Software as a Medical Device solutions, they need a compliant infrastructure and regulatory expertise to ensure their products are designed and maintained in an environment that is compliant with international quality and regulatory standards. Building these capabilities within a pharma or medtech company impacts their time to market, increases headcount costs, and introduces additional regulatory and audit exposure.

  2. Our BrightInsight Platform can support our customers’ advanced use cases across the digital health regulatory maturity curve.

    BrightInsight is built from the ground up to securely manage highly regulated medical device data and personal health information. Flex Digital Health has put the people, technology and processes in place to monitor security and threat prevention to meet global compliance standards.

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