Atmo Biosciences Successfully Completes ISO 13485:2016 Audit
Atmo Biosciences is pleased to announce that it has successfully completed the audit of its Quality Management System to obtain ISO 13485:2016 accreditation.
The audit was performed by BSI (www.bsigroup.com) for the design and manufacture of the Atmo Gas Capsule System.
ISO 13485:2016 is an internationally recognized quality standard that is specific to the medical device industry and has been developed to ensure the quality of medical device design, development, and manufacturing. In order to receive certification, organizations must demonstrate that their internal Quality Management System ensures the consistent delivery of medical devices and related services that meet customer and regulatory requirements. ISO 13485:2016 certification is expected for any companies that wish to market their medical devices in international markets such as Europe or Canada.
Malcolm Hebblewhite, Atmo CEO and Managing Director commented: “As we move into an expanded international clinical program for our lead indications and target the commencement of initial commercial sales in 2023, it is increasingly important to be able to demonstrate that we have the appropriate quality management system in place. It is a credit to the Atmo team that we have successfully completed the ISO 13485:2016 audit. This is a significant milestone in our evolution as a commercially focused medical device company.”
The Atmo Gas Capsule is the world’s first, ingestible gas-sensing capsule and is being developed for monitoring gastrointestinal health and microbiome function. Over 570 Atmo Gas Capsules have been ingested across 12 different clinical studies which have been conducted by Atmo and other commercial and academic research groups globally. Atmo is currently focusing its internal clinical development programs for the Atmo Gas Capsule on two functional gastrointestinal disorders—gut motility and SIBO (small intestinal bacterial overgrowth).