News

Is Your Product a Medical Device or a Borderline Product?

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...

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FDA Updates Their CLIA Waiver Process

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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MHRA: Standalone Software and Apps

MHRA: Standalone Software and Apps

The Medicines and Healthcare Products Regulatory Agency (MHRA) guidance document: Medical device stand-alone software including apps (including IVDMDs) serves as a replacement for the previous MHRA guidance on medical device standalone software and apps. It...

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