Although the Gluco Quantum® is designed for home health and consumer use, it is acknowledged that certification to validate the accuracy and risk is desired. Prior to Covid-19, the Gluco Quantum® was undergoing the process for ISO 13485 certification.

Under current guidelines, the Gluco Quantum® is classified as a Type II medical instrument for low risk due to its noninvasive functions.

Recently, the FDA has recognized and acknowledged that digital health technologies can empower consumers to make better informed decisions about their own health and provide new options for facilitating prevention, early diagnosis of possible life-threatening diseases and management of chronic conditions outside of traditional care settings. Technologies that assist in diagnosis, treatment options, storing and sharing health records can enable more efficient clinical practice.

The FDA recognizes that digital health technologies can provide powerful tools for public health officials and the public in the management of the COVID-19 response by helping public health officials reach and communicate with a vast number of people more quickly, efficiently, and effectively.

ISO 13485

ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system.

CE Mark (Europe)

CE Marking in the medical sector indicates that healthcare appliances – meet legislative requirements in full. The certification that supports the CE Mark is ISO 13485.

A CE Medical mark is evidence that it follows EU Directives required to meet specific standards of performance, quality, safety, and efficacy for the product type

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.

The announcement by the FDA that it will use ISO 13485 in replacing its current quality system regulation, is an important next step in the recognition this standard has already gained globally.

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