subscribe | login or register


Home

  • Magazine
    • Archives
    • Newsletters
      • Subscribe to Newsletters
    • Editorial Advisory Board
    • Join IVDT Reader Board
    • Editorial Calendar
  • News
    • New Product Review
  • Find Suppliers
    • Online Exhibitor Spotlight
    • Online Supplier Spotlight
  • Blog
  • Ask the Experts
  • Events
    • IVDT Conference
    • MD&M West
    • AACC Tradeshow Advisor
    • Virtual Conference
  • Webcasts
  • Video
  • Resources
    • DX Directions
    • Industry Organizations
    • White Papers
    • Careers
    • MDRWeb
    • Regulatory Tool
  • About
    • IVDT Media Kit
    • Subscription Services
    • Contact Us
    • Submit Editorial
    • Staff
  • Members
    • Register
    • Login
  • Qmed
Popular Topics
  • Assay Development
  • Beyond Clinical Diagnostics
  • Business Strategy
  • Detection Technologies
  • Diagnostic Executive Profile
  • Diagnostics for Personalized Medicine
  • Emerging IVD Companies
  • Global Diagnostics
  • Instrumentation Development
  • IVD Industry Overview
  • Laboratory Automation
  • Manufacturing & Processing Technologies
  • Marketing
  • Medical Design Excellence Awards
  • Molecular Diagnostics
  • Outsourcing for IVD Manufacturers
  • Point-of-Care Technologies
  • Regulation and Compliance
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 In July, FDA released its draft guidance document regarding companion diagnostics, which offers the agency's current thinking on this area.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'

Top 10 Molecular Diagnostics Companies

Top 10 molecular diagnostics companies by molecular-related revenues in 2012.

A Risk-Management Roadmap for Clinical Laboratories

Any IVD device can and will fail under certain circumstances. CLSI EP 23 helps labs to manage and mitigate risk. Manufacturers also stand to benefit from knowledge of the guidelines.

Roche Cuts 170 Jobs in Germany and Conneticut

Remaining employees and other resources will be shifted to the company’s diagnostics division.

More Features

  • Thermo Fisher Acquires Life Technologies for $13.6 Billion
  • In Case You Missed It: Infographic Highlights the Value of IVDs
  • LipoScience, HTG Molecular Diagnostics, BioNano Genomics Named MDEA Finalists
IVDT Insight Blog
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
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
Cizzle, Fujirebio Join Forces to Develop Lung Cancer Dx
MSU Researchers Develop New Malaria Diagnostic
Abbott Announces CE Mark for Diabetes Dx/Monitoring Test
IVDT Product News
Cell Fusion System
Monoclonal Antibodies to Chikungunya Virus
Stepper Motor Drive Module
Ultra-Low-Pressure Sensors
Stockroom Inventory Tracking Software
Laser Micromachining
Microflow switch and bubble detector
Target amplification
Mass spectrometry protein analysis
Portable nephelometer
Trends & Perspectives
Your Osteoporosis Test Is in the Nail
Idaho Technology Becomes BioFire Diagnostics, Advances Clinical Diagnostics Goals
European Commission Publishes Guidance on Medical Software Used in IVDs
Ventana Strikes Numerous Deals With Pharma Firms This Year
Our Most-Read Story of 2012: U.S. IVD Market to Exceed $9.5 Billion by 2017
Bill proposes modernizing IVD regulations
FDA To Exempt Some IVDs from 510(k) Clearance
Report offers insights into IVD M&A activity
Samsung Electronics Lengthens its Dx Reach
OCD’s “Know Your Numbers” campaign pushes forward
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?
FDA's proposed CLIA waiver application guideline
Regulation of IVDs in Australia
Lateral-flow assays: Designing for automation
Regulatory options for IVDs: Selecting the best path to market
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
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?
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?

Qualified Suppliers to the IVD Industry

  • White Papers
  • Supplier News
  • Videos
  • Design Tips for Rapid Injection Molding
  • Smoothing the Path to Secure Smart Grids for Integrators
  • Smoothing the Path to Secure Smart Grids for Manufacturers
  • Overview of the Nitrogen Dioxide Sterilization Process
  • The Four Myths of Time and Materials Estimates
view more
  • The Evolution of Coatings for Endovascular Devices
  • IQMS Customer Wins Manufacturer of the Year Award
  • Margo Martin Named Global Account Manager
  • Hybrid 90-2
  • Minnetronix to Showcase Remote Medical Device Monitoring and Intelligence System at MD&M East: June 18-20
view more
  • Henkel Corporation's Loctite's Wide Range of Adhesives for the Medical Manufacturing Market
  • JOHNSON MATTHEY at MD&M West 2011
  • Ethylene Oxide Sterilization Validations
  • maxon corporate video
  • Qosina at MD&M West 2011
view more

Advertisers | Privacy Policy | Contact | Subscribe | Sitemap
© UBM Canon 1996-2013

Related Sites from UBM Canon:
- Qmed - Qualified Medical Suppliers
- Medical Device + Diagnostic Industry
- European Medical Device Technology
- Medical Product Manufacturing News
- Medical Electronics Design
- OrthoTec
- China Medical Device Manufacturer
- medtechinsider
- medtechinsider auf Deutsch
- Pharmaceutical & Medical Packaging News
- Pharmalive