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The various barriers and challenges to equitable access to IVDs
Supply chain, laboratory services and infrastructure
Accessing Health Services
Cost
Improving access
The Future of IVDs
Access to basic diagnostics is vital for cancer
Access to diagnostics is poor: Commission findings
How does poor access to basic diagnostics impact cancer?
Implementing the Commission recommendations
Intro
Scope of IVDs
Home pregnancy tests
Human Factors in Medical Devices
How are IVDs and medical devices the same from a manufacturing perspective?
Origin of IVDs
What are some of the types of products and services that you do and help companies with?
Investigative devices
Thoughts on EUA-only applications
Conclusion
Ibd Directive
Three Main Routes for Compliance with the Regulation
A Draft Guide for Health Institutions Who Manufacture and Use in-House Ibds in Ireland
What Is an in-House Ibd
Requirements for in-House Ibd
Public Declaration
Classifying Ivds
Reviewing Experience Gained from Clinical Use
Summary
Cross-Reactivity Testing
NORDIC BIOSCIENCE
Biomarkers - an example in NAFLD/NASH
Define the Context of Use (COU) for the biomarker
Biomarkers: Involvement of Regulatory Authorities-US
IVD validation according to FDA requirements (CLSI)
A clinical validation requires 2 clinical studies
Criteria for granting Breakthrough for a biomarker
Label information for a Biomarker
Qualification - supporting clinical development
Points of interest - ECLIPSE
What Is an Introdiagnostic Medical Device
What Is a Research Use Only Product
What Is Iuo
Reaction of the Eu
Article 5 5 Requirements
What Is Accepted Use of Research
What Type of Quality Control Materials Do You Use
Safety and Performance Requirements
What Are the Consequences for a Laboratory Using an Ruo Material When an Ivd Approved Material Is Available
Wrap Up