Quality and Compliance
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.
FDA registered and 21 CFR part 11 compliant
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
CE Mark Compliant
Glooko affirms that it has met all the requirements of the Medical Device Directive (MDD 93/42/EEC) for CE marking (“Conformité Européenne”) in the European Economic Area (EEA). The CE marking signifies that our products have met health protection, safety, performance characteristics and environmental protection standards.
Manufacturers in the EU and abroad must meet CE marking requirements, as applicable in order to market their products in Europe.
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 established internal policies to support that protection, as well as external notice of what data they collect, for what purposes, and how they use them
HIPAA COMPLIANT
HIPAA compliance involves fulfilling the requirements of the Health Insurance Portability and Accountability Act of 1996, its subsequent amendments, and any related legislation such as HITECH
Compliance helps ensure that technical, physical and administrative safeguards are in place and adhered to that they comply with HIPAA to protect the integrity of PHI
