Quality/Compliance

Quality and Compliance.

Get extra peace-of-mind with Glooko’s world-class quality management systems.

Quality Policy.

Glooko maintains our commitment to high quality products and services with an effective quality management system that meets applicable regulations through training, objectives, standards and effective communication.

We continually develop and improve Glooko products and services to ensure they exceed patient, health care provider and other user needs and expectations.

ISO certified.

ISO 13485 is an Internationally recognized quality system standard that describes requirements for Quality System practices and procedures in the design, development, production, and delivery of medical devices, including digital health software. Because Glooko software is classified as medical device software, we are required to meet this comprehensive Quality System standard, including the cybersecurity expectations associated with the Standard.

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FDA registered and 21 CFR part 11 compliant.

The Glooko platform is registered with the FDA and has received confirmation of 21 CFR Part 11 compliance via an audit conducted by a former FDA Part 11 SME and author of several FDA guidance documents.

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GDPR Compliant.

Glooko is committed to protecting personal data in accordance with the EU General Data Protection Regulation (GDPR), which mandates strong data protection safeguards and guarantees of individual data rights. Glooko has extablished internal policies to support that protection, as well as external notice of what data they collect, for what purposes, and how they use it.