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Hiring a lab consultant can bring significant benefits to the planning, design, and operation of a laboratory. Here are some key reasons to consider working with a lab consultant: They have Expertise in Lab Design and Functionality. Consultants specialize in creating efficient, functional, and compliant labs tailored to specific industries (e.g., research, clinical, or educational)....

An in-office laboratory can provide numerous benefits to a medical practice, improving patient care, efficiency, and profitability. Here are several key advantages: Enhanced Patient Care Faster Diagnostics: Immediate access to lab results can lead to quicker diagnosis and treatment, improving patient outcomes. Convenience: Patients can have tests done during their appointment, reducing the need for...

The FDA has issued a significant final rule that changes the regulatory landscape for Lab Developed Tests (LDTs). This new rule, which takes effect on July 5, 2024, ends the agency’s long-standing practice of exercising enforcement discretion for most LDTs. The FDA now explicitly includes LDTs under the definition of in vitro diagnostic (IVD) devices...

Keeping up with CMS (Centers for Medicare & Medicaid Services) regulatory changes can be challenging due to the frequent updates and the complexity of the regulations.   Hiring a laboratory consultant who specializes in laboratory compliance can greatly enhance your lab’s ability to stay current with changing regulations. Key Considerations for Selecting the Right Consultant...