Clinical performance evaluation – are you up to speed?

The EU Medical Device Regulation came into force on May 26 2021, and the In-Vitro Diagnostic Devices Regulation from 26 May 2022. The regulations reflect the developments in the sector over the past 20 years – new medical devices must comply with the new regulations when they come to market. Similar regulations exist in the…

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A Candidate-Driven Market for Clinical Trials

Many clinical trials were stopped during the pandemic, and there were also delays to approvals for new clinical trials to go ahead. Now that we are coming out of the main restrictions of the pandemic, clinical trials are ramping up, and need clinical monitoring professionals in order to meet strict regulatory requirements. What is clinical…

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