From the Desk of Jim Kasic Looking Back, Looking Ahead: Years of Explosive Growth I think most businesses would agree it has been an interesting year, and here at Boulder iQ, it’s no exception. Coming out of the COVID-19 pandemic, we’ve seen that the market has turned sharply upward. In the medical device space, companies […]

The New EU: IVDR (In Vitro Diagnostic Medical Devices Regulation) and Economic Operators Mike Andrews, Ph.D., Vice President, Regulatory and Quality, Boulder iQ Introduction The EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) will replace the EU In Vitro Diagnostic Medical Devices Directive 98/79 (IVDD).  Compliance with the IVDR is required no later than May […]

December 20, 2018