Diabetes software company Glooko announced today that its Mountain View, Calif., and Gothenburg, Sweden, sites have received joint ISO 13485:2016 certification from accredited certification body Intertek Testing Services.
ISO 13485 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 evaluations of its corporate quality management system via a pre-certification audit in June 2019 and certification audits in September 2019 (Mountain View) and October 2019 (Gothenburg), with no nonconformities noted in the certification audits.
The 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, according to the company.
“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 Glooko CEO Russ Johannesson in a news release. “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.”
Quality management in digital health is about more than simply developing and testing software, the company added.
“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.
