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Is Your Product a Medical Device or a Borderline Product?

Jul 25, 2023 | News

The demand for medical devices in the UK has soared, prompting manufacturers to navigate complex classifications. While global acceptance is a factor, it doesn’t always align with the standards set by the MHRA. To ensure compliance, manufacturers must decode the UK’s...

FDA Updates Their CLIA Waiver Process

Jul 20, 2023 | News

The FDA has updated their CLIA Waiver Process in the following ways:  CLIA Waiver by Application  The FDA has updated its CLIA waiver process to provide manufacturers of in vitro diagnostic (IVD) tests with clearer guidelines and requirements. Under the Clinical...
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