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Ask The Experts

What is the regulation regarding the use of raw materials not made under GMP or tested by the supplier with non-validated test methods? Is it acceptable to mitigate such perceived issues at one’s supplier with risk analysis-driven performance verification

Our company’s CEO assumes that IVDs are low-risk products and that ISO 13485 certification is merely a marketing tool for EU sales. Thus, satisfying the Notified Body (NB) auditors is important but establishing a functioning quality system is unnecessary.

During installation of an automated urine microscopy analyzer we find that the automat gives higher cell counts pro high power fields than seen under the microscope. The automatic count is equal to that – established with a microscope with the same magnif

IVDT Insight Blog

EKF Molecular To Launch Cancer Gene Detection Technologies at ASCO 2013

Researchers at John Hopkins Develop Postpartum Depression Diagnostic

Quest Diagnostics Buys Clinical and Toxicology Labs from Humana

The Chemical Angel Network: A New Breed of Angel Network

Australian Regulators Propose Changes for IVDs

Angelina Jolie's Announcement Keeps Myriad Genetics in Spotlight

FDA Approves Lung Cancer Diagnostic by Roche

Online Supplier Spotlight

Hamilton Company

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Your Osteoporosis Test Is in the Nail

The IVD Miniaturization Paradigm

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Microfluidics-based lab-on-a-chip systems

A phased approach to the development and commercialization of new immunodiagnostic assays

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Boom Times for China’s IVD Market

Top 10 Molecular Diagnostics Companies

A Risk-Management Roadmap for Clinical Laboratories

In Case You Missed It: Infographic Highlights the Value of IVDs

At HiberGene, Molecular Diagnostics Tackles Meningitis

Your Osteoporosis Test Is in the Nail

The IVD Miniaturization Paradigm

Innovations in Anatomic Pathology Lab Automation

Boom Times for China’s IVD Market

Top 10 Molecular Diagnostics Companies

A Risk-Management Roadmap for Clinical Laboratories

In Case You Missed It: Infographic Highlights the Value of IVDs

At HiberGene, Molecular Diagnostics Tackles Meningitis

Your Osteoporosis Test Is in the Nail

The IVD Miniaturization Paradigm

Innovations in Anatomic Pathology Lab Automation

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Qualified Suppliers to the IVD Industry

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IQMS Customer Wins Manufacturer of the Year Award
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Qosina at MD&M West 2011

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