Bluebee achieves ISO 13485 Medical Device Quality Standard Certification
Rijswijk, The Netherlands: 15 June 2018 – Bluebee, a global bioinformatics solutions provider, has announced today that it has been awarded the ISO 13485:2016 certification. ISO 13485 is an internationally recognized medical device quality management systems standard, which was awarded to Bluebee for its design and development of software solutions and data processing algorithms intended for use in diagnostics and clinical reporting.
This certification is awarded for quality management systems in medical devices and adds to Bluebee’s already existing ISO/IEC 27001:2013 information security management systems certification. The achievement of this accreditation further demonstrates Bluebee’s commitment to providing quality risk-based software development, regulatory compliance, quality management, and highly secured genomic data analytical workflows to clinical laboratories and diagnostic assay kit providers.
More info on Bluebee’s website.