Blog Archives - Labshire

Lab Developed Tests – Are You Ready?

February 9, 2024
Camille Forte
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SITUATION The U.S. Food and Drug Administration (FDA) recently proposed a rule to increase oversight of laboratory-developed tests (LDTs). 21 CFR 809 In Vitro Diagnostic Products for Human Use was passed by Congress in 1976 to provide a means for regulating commercially developed laboratory test systems. At that time many…

August 24, 2023
Camille Forte
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Do You Need Consulting Services to Successfully Set Up Your Laboratory? Setting up and operating a laboratory can be a daunting task. Given their complexity, dealing with laboratory facilities, instrumentation, and operations is a complex and demanding endeavor. The laboratory design and facilities must match sophisticated instruments as well as…

Reasons Why EHS Consultants Are Vital to Your Laboratory

Reasons Why EHS Consultants Are Vital to Your Laboratory Laboratories play an essential role in scientific research, testing, and analysis, but they also pose significant health and safety risks to workers, visitors, and the environment. As such, laboratories must adhere to strict regulations and guidelines to ensure compliance with environmental,…

December 8, 2022
James Blackwell
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Why Specified Requirements are Key for Organizational Accountability: Supplier Management – An Overview When it comes to identifying, qualifying, selecting, and monitoring approved suppliers and/or materials and equipment, certain specified requirements (SR/URS) and/or user requirement specifications (URS) must be met. These requirements help to ensure that only the best and…

Blog

Lab Developed Tests – Are You Ready?

Why You Need Consulting Services to Successfully Set Up a Laboratory.

Reasons Why EHS Consultants Are Vital to Your Laboratory

Supplier Management – An Overview

Inside The FDA’s Proposal to Regulate Laboratory Designed Tests

Labshire, LLC is Attending the Executive War College Conference 2024

Lab Developed Tests – Are You Ready?

Contact Us

Blog

Lab Developed Tests – Are You Ready?

Why You Need Consulting Services to Successfully Set Up a Laboratory.

Reasons Why EHS Consultants Are Vital to Your Laboratory

Supplier Management – An Overview

Contact Us

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