Indigo BioAutomation, Inc. Receives ISO 13485:2016 Certificate
Indigo’s Quality Management System demonstrates excellence by obtaining an ISO 13485:2016 certificate
Carmel, IN, Friday July 20th 2018 - Indigo BioAutomation, Inc. (Indigo), a leading provider of software solutions for laboratory automation, announced today that it has received an ISO 13485:2016 certificate from British Standards Institute (BSI) Group. This certificate demonstrates the organization’s ongoing commitment to providing the highest quality medical device solutions, products, and services to its customers. Indigo previously held ISO 9001:2008 certification.
The International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards for the implementation of quality management systems. ISO 13485:2016 identifies the requirements for a medical device focused quality management system to ensure an organization has the ability to consistently meet both regulatory and customer requirements.
“This certification is a testament to the high level of performance and quality control we expect at Indigo BioAutomation during the development, production and support of our software,” commented Randall Julian, President, Founder and CEO of Indigo. “This level of rigor is important to ensuring our software continues to provide accurate, reliable, and reproducible results for our customers.”
Indigo registered with FDA and listed their flagship product, ASCENT™, as a class I exempt medical device in September of 2017.
“Receiving this ISO13485:2016 certificate strongly reflects Indigo’s commitment to quality as well as our ability to bring safe and effective products to the market,” said Brian Huff, Director of QA/RA for Indigo. “This certificate also demonstrates Indigo’s drive to raise the level of quality throughout the organization and satisfy a very rigorous standard for medical device quality systems in an innovative manner.”