Bluebee recently announced that it has received ISO 13485 medical device quality standard certification for its design and development of software solutions and data processing algorithms intended for use in diagnostics and clinical reporting.
The certification body BSI certified that Bluebee’s design, development, installation, testing and servicing of custom-made software solutions and data processing algorithms that are designed for diagnostics and clinical reporting is compliant with ISO 13485:2016 standards. Bluebee’s certification adds to the company’s already existing ISO/IEC 27001:2013 information security management systems certification.
“This achievement represents our commitment to providing our clinical laboratory customers and assay kit partners with the highest quality products within an environment of continuous rigor and improvement,” Marc Gielis, chief operations officer at Bluebee, said.
Bluebee currently provides risk-based software development, regulatory compliance, quality management and highly-secured genomic data analytical workflows to clinical laboratories and diagnostic assay kit providers.
