Co-Diagnostics to undergo ISO 13485:2016 Audit
Co-Diagnostics said it will be undergoing a Stage II Upgrade Assessment Audit to ISO 13485:2016. The International Organization of Standards is a non-government entity comprised of academic and industry professionals which certifies that companies are compliant with industry-standard best practices in their production and operations. ISO 13485:2016, the international standard for medical device quality management systems, differs from the 2003 version of the standard in its increased emphasis on risk management. It also harmonizes more closely the quality system regulations found in FDA 21 CFR Part 820, the law for medical device companies manufacturing or selling products for the US. The audit will be performed this week by DQS Inc., a global certification body for management systems.