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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
Archived Webcast
The Regulation of Companion Diagnostics: Current Status and Updates
Companion diagnostics for personalized medicine is the most important emerging trend in the IVD industry today. In July, FDA released its draft guidance document regarding companion diagnostics, which offers the agency's current thinking on this area. In an effort to provide further clarity on this matter, the editors of IVD Technology have put together a special Webcast on the regulation of companion diagnostics.
Queue 'Featured Content'

Fact-Check: Clarifying the Myriad Genetics Supreme Court Decision for Industry

Thomas M. Cooley Law School professor and registered patent attorney David C. Berry explains the Myriad Genetics Supreme Court decision and what the implications are for industry.

Will Ruling on Human Gene Patents Hurt or Help IVD Innovation?

 It's hard to argue with a unanimous Supreme Court decision, says Glen Freiberg, president of RQC Consulting and member of the IVD Technology editorial advisory board. But...

Siemens Chief Scientific Officer Donnelly to Kick Off "Design for Speed" Track at MD&M East Conference

The Siemens CSO insists "innovation" alone won't get IVD companies where they want to be. Meeting customer needs and making continuous quality improvements are key to making...

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Fact-Check: Clarifying the Myriad Genetics Supreme Court Decision for Industry
Siemens Chief Scientific Officer Donnelly to Kick Off "Design for Speed" Track at MD&M East Conference
Fundamentals of Contract Manufacturing
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
OIVD sends out first warning letter
Regulatory requirements for IVDs in Japan
Pivotal Clinical Investigations Draft Guidance: IVD Applications
Developing highly sensitive, more-reproducible lateral-flow assays Part 1: New approaches to old problems
Assessing the IVD markets of Brazil and Mexico
Regulation of IVDs in Australia
Point-of-Care Molecular Diagnostic Testing
Tools for Molecular Diagnostics
Fact-Check: Clarifying the Myriad Genetics Supreme Court Decision for Industry
Siemens Chief Scientific Officer Donnelly to Kick Off "Design for Speed" Track at MD&M East Conference
Fundamentals of Contract Manufacturing
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
Adapting life sciences technologies to IVDs
Fact-Check: Clarifying the Myriad Genetics Supreme Court Decision for Industry
Siemens Chief Scientific Officer Donnelly to Kick Off "Design for Speed" Track at MD&M East Conference
Fundamentals of Contract Manufacturing
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

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