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 (March 7, 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 (February 21, 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 (January 11, 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 (January 11, 2024) by Andy Chasteen […] Read More… from MDC Associates selected as a spoke of ARPA-H Investor Catalyst Hub network
Breakthrough Devices: Recent Changes and Expanding Initiatives by FDA Posted on October 31, 2023 (January 11, 2024) by Andy Chasteen […] Read More… from Breakthrough Devices: Recent Changes and Expanding Initiatives by FDA