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Outside the Lab Regulation and standards, Quality assurance and quality control, Point of care testing, Laboratory management

A Distant Dream

India’s laboratory infrastructure requires regulation and standardization to make it safe for billions of patients

Rohit Jain | | Opinion

What exactly is an in vitro diagnostic medical device (IVD)? It’s the instrumentation needed to carry out a particular pathology test (or tests) on human samples to assist in clinical diagnosis or treatment decision-making. These devices include the laboratory or point-of-care devices, calibrators, controls, kits, reagents, and accessories used to perform diagnostic tests. IVDs are distinct from medical devices in that they never come into direct contact with the patient; however, they still have an impact on life-changing, and potentially life-saving, treatment decisions.

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Outside the Lab Regulation and standards, Quality assurance and quality control, Point of care testing, Laboratory management

About the Author

Rohit Jain

Consultant Pathologist at Santokba Durlabhji Memorial Hospital and Founder Secretary of the Practicing Pathologists Society, Jaipur, Rajasthan, India.

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