Blog Archives - Labshire

15 May 24

FDA Final Rule | Labshire

By James Blackwell, President, Windshire Group, LLC and Labshire, LLC May 14, 2024 Download this White Paper here | FDA Final Rule IVDs | Labshire.com May 2024 As we anticipated and reported in February, the FDA issued a final rule amending its regulations to state explicitly that in vitro diagnostic…

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…

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FDA Final Rule | Labshire

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

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