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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
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
MSU Researchers Develop New Malaria Diagnostic
Cizzle, Fujirebio Join Forces to Develop Lung Cancer Dx
AACC Tradeshow Advisor
IVDT TSA for event coverage

Volume 3

  • July 2012, Volume 3, No. 1
    • Everything you need to know to prepare for this year's show and conference.
    • Hooray for . . . AACC!
    • Introduction to the AACC Annual Meeting
    • Clinical Lab Expo 2012 Preview
    • AACC 2012 Conference Preview
    • The Man Behind the Meeting
    • Products, Technologies, and Services at AACC/Clinical Lab Expo 2012
    • Welcome to Hockeytown
    • Dining Out in Downtown L.A.
    • Downtime in Downtown: Attractions Near the Los Angeles Convention Center

Volume 1

  • July 2010, Volume 1, No. 1
    • So Much To Do, So Much To See
    • Getting Around Atlanta
    • International Market Briefing
    • Clinical Lab Expo Preview
    • Conference Preview
    • Introduction to the AACC Annual Meeting
    • Interview: AACC Industry Division Chair
Most Recent
  • Most Emailed
  • Most Viewed
  • Top Rated
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
EU IVD Regulation: Something Wicked This Way Comes?
Regulatory options for IVDs: Selecting the best path to market
FDA's proposed CLIA waiver application guideline
Design control practices for IVDs
Microfluidics-based lab-on-a-chip systems
A phased approach to the development and commercialization of new immunodiagnostic assays
Organizing performance evaluation to meet IVD Directive requirements
The place of gold in rapid tests
Top 10 Molecular Diagnostics Companies
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
EU IVD Regulation: Something Wicked This Way Comes?
Predicting a Positive Outcome for a Negative-Predictive Appendicitis Test
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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