Laboratory Developed Tests: Overview of the Regulatory Framework in Europe vs. USA
In this white paper, our regulatory team presents the frameworks governing Laboratory Developed Tests in Europe and the USA, and discuss...
In this recorded panel discussion, members of different healthcare organizations discuss the potential impact of the FDA Rule on LDTs, near term / long term implications, and stakeholder’s priorities for minimal disruption. By watching this panel discussion, you will:
- Gain an understanding of the FDA’s Rule on LDTs, its purpose, significance and impact on the testing industry;
- Understand how certain organizations are managing this, some high level near term and long-term strategies;
- Become familiar with the core concepts, impact on their organization type, and understanding of evolving regulatory landscape.
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White Paper: Laboratory Developed Tests: Overview of the Regulatory Framework in Europe vs. USA
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The Innovation Imperative for Growth Stage Medical Technology Companies
During this session, Brandon Bogdalek will interview panelists from the medical technology space. The panelists will discuss the innate need to...