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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

Australian Lawmakers Mull IVD Regulatory Changes

Angelina Jolie's Announcement Keeps Myriad Genetics in Spotlight

FDA Approves Lung Cancer Diagnostic by Roche

Cizzle, Fujirebio Join Forces to Develop Lung Cancer Dx

MSU Researchers Develop New Malaria Diagnostic

Abbott Announces CE Mark for Diabetes Dx/Monitoring Test

Aviir Inc. Extends Services with an Inherited CVD Genetic Test Menu

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