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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
Exact Sciences Raises Funds for Cologuard Diagnostic With Stock Sale
DxInsights and AdvaMedDx Publish Free Informational Report on Molecular Diagnostics
Siemens Developing Companion Diagnostic for In-Development Janssen Heart-Failure Drug
BIO Issues Statement Regarding Myriad Genetics Decision
Clinical-Test Reimbursement Bill Sports New Name, Gains More Cosponsors
Investors Wanted for Magnet-Based Malaria Diagnostic
Will Ruling on Human Gene Patents Hurt or Help IVD Innovation?
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