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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

FDA Approves Roche's HbA1c Test for Diagnosing Diabetes

Corgenix and Eli Lilly Join Forces to Develop Oncology Dx

UC Irvine Researchers Develop Urine Prostate Cancer Dx

New Medicare Test Reimbursement Bill Introduced; Replaces Dead H.R. 6446 Bill

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

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