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Assay Development
Beyond Clinical Diagnostics
Business Strategy
Detection Technologies
Diagnostic Executive Profile
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Emerging IVD Companies
Global Diagnostics
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IVD Industry Overview
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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

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?

Resources

IVD Technology editors have compiled a list of useful resources. New resources are added regularly.

Industry Organizations
White papers
Medical Device Industry Career Center
Medical Design Excellence Awards
Medical Device Register

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

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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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Qualified Suppliers to the IVD Industry

White Papers
Supplier News
Videos

Solving Proprietary Process Problems
Drive Down the Cost of Flex Circuitry
Inspection of Over Molded - Encapsulated Medical Devices
Advancing Medical Device Applications with Capacitive Tactile Sensors
From Four to One: Custom Profile’s Success with Comprehensive ERP Software from IQMS

Brandon True Joins Chemsultants International as a Polymer Chemist
Foster Propell™ Compounds Improve Catheter Manufacturing in Low Durometer Polymers
SMC Ltd. Acquires New Building To Expand Its Medical Design And Product Development Center
Putnam Plastics Completes Facility Expansion for Advanced Extrusions Used in Medical Devices
LED Light-Curing System Reduces Cost and Improves Process Control

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

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