Is Your Product a Medical Device or a Borderline Product?

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

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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