Glooko Receives 13485:2016 Certification For California and Sweden Sites

The remote monitoring platform for diabetes patients passed audits of its corporate quality management system this year.

• By Haley Samsel
• Dec 12, 2019

Diabetes data management company Glooko has received joint 13485:2016 certification in its Mountain View, Calif. and Gothenburg, Sweden locations, the company announced this week.

The certification aims to show regulators, business partners and the wider medical community that a company has met certain requirements for design, development, production and delivery of medical devices.

Glooko received a pre-certification audit of its corporate quality management system in June and passed two certification audits in September and October. 

“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,” CEO Russ Johannesson said in a public statement from the company.

Glooko executives noted in the statement that the certification has a special meaning when it comes to their digital health software, which helps diabetes patients and their providers meet their clinical needs through remote monitoring.

“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,” Mary Beth McDonald, Glooko’s senior director of regulatory and quality management, said.