Four New Rapid AST Solutions Hit the Market over Six Months Posted on July 31, 2024 (August 2, 2024) by Andy Chasteen […] Read More… from Four New Rapid AST Solutions Hit the Market over Six Months
How to Build a Culture of Quality in Medical Device Organizations Posted on May 24, 2024 (May 24, 2024) by Andy Chasteen […] Read More… from How to Build a Culture of Quality in Medical Device Organizations
FDA Finalizes Landmark Ruling: LDTs Officially Regulated as Medical Devices Posted on April 30, 2024 (April 30, 2024) by Andy Chasteen […] Read More… from FDA Finalizes Landmark Ruling: LDTs Officially Regulated as Medical Devices
The FDA’s Reclassification of IVDs and Implications for LDTs Posted on March 22, 2024 (March 22, 2024) by Andy Chasteen […] Read More… from The FDA’s Reclassification of IVDs and Implications for LDTs
MDC Welcomes Matthew Faron, PhD Posted on March 7, 2024 (September 10, 2024) by Andy Chasteen […] Read More… from MDC Welcomes Matthew Faron, PhD
Updates from Jan 2024 CLSI AST Subcommitee and Working Groups Posted on February 20, 2024 (October 4, 2024) by Andy Chasteen […] Read More… from Updates from Jan 2024 CLSI AST Subcommitee and Working Groups
EU Commission Proposes Extension of IVDR Compliance Deadlines Posted on January 30, 2024 (January 30, 2024) by Andy Chasteen […] Read More… from EU Commission Proposes Extension of IVDR Compliance Deadlines
FDA and CMS Reject the Notion of Expanding CLIA to Oversee LDTs Posted on January 23, 2024 (January 24, 2024) by Andy Chasteen […] Read More… from FDA and CMS Reject the Notion of Expanding CLIA to Oversee LDTs
FDA’s Proposed Regulations for Laboratory Developed Tests Posted on January 11, 2024 (September 10, 2024) by Andy Chasteen […] Read More… from FDA’s Proposed Regulations for Laboratory Developed Tests
MDC Associates selected as a spoke of ARPA-H Investor Catalyst Hub network Posted on December 15, 2023 (September 10, 2024) by Andy Chasteen […] Read More… from MDC Associates selected as a spoke of ARPA-H Investor Catalyst Hub network