Glooko Achieves ISO 13485 Certification

Glooko, a developer of diabetes data management, announced that its Mountain View, Calif., and Gothenburg, Sweden, sites have received joint ISO 13485:2016 certification from accredited certification body Intertek Testing Services NA Ltd. This certification demonstrates Glooko’s commitment to establishing a compliant quality management system and following practices and procedures that meet customer, safety and regulatory requirements applicable to medical devices. It verifies for regulators, strategic partners, and the diabetes community that Glooko is committed to ensuring the quality and safety of its digital health products and services.

ISO 13485 is an International Organization for Standardization (ISO) standard that describes the requirements for comprehensive practices and procedures for the design, development, production, and delivery of medical devices, including digital health software. To become ISO 13485 certified, Glooko underwent thorough evaluations of its corporate quality management system via a Stage 1 pre-certification audit in June 2019 and Stage 2 certification audits in September 2019 (Mountain View) and October 2019 (Gothenburg), with zero Stage 2 nonconformities noted.

“Organizations in the medical device industry are required to demonstrate their quality management processes and ensure they’re following regulations and standards for developing safe and reliable products,” said Russ Johannesson, CEO of Glooko. “Our certification to ISO 13485 is an important milestone that confirms our quality management system has met internationally-recognized requirements, and that Glooko is committed to ongoing compliance and improvement.”

Because digital health products like Glooko must comply with regulatory standards that meet the quality, safety and clinical needs of people with diabetes and their providers, quality management in digital health is about more than simply developing and testing software.

“Being certified to the ISO 13485 standard is especially important because digital health software is more than a tech product—it is a healthcare product with global quality and safety requirements,” said Mary Beth McDonald, senior director of regulatory and quality management for Glooko.

Beyond regulatory compliance, ISO 13485 certification demonstrates the robustness of Glooko’s quality management system to the U.S. Food and Drug Administration (FDA), European Union, and Glooko’s strategic partners.
 
Glooko’s universal diabetes software products provide insights to improve outcomes for people with diabetes and their care teams. The Glooko product suite contains the Glooko and diasend diabetes management solutions, which integrate with many of the EHR systems used today. Both systems synchronize data from more than 190 diabetes devices and activity trackers, and deliver integrated, timely and useful patient data, including glucose levels, blood pressure, weight, and food, insulin and medication intake. The company’s solutions cover more than 2.2 million people with diabetes and are used in more than 9,000 clinic locations in 24 countries across 15 languages.