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Tag Archives: cer

Mayday, Mayday! Regulatory compliance doesn’t have to be an emergency!

Here at Medilink North of England, we are often asked by our clients: ”What’s the biggest cause of delay and failure when obtaining regulatory approvals for a new medical device in Europe? Is it issues with technical documentation, perhaps? Device labelling and IFU? Post Market Surveillance?” The answer is having the right clinical evidence in…
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