ABHI LEADERSHIP
Focus on Regulation
Phil Brown Director, Regulatory & Compliance
During the early stages of the COVID-19 pandemic, there was a desperate need for emergency ventilators, to ensure patients were cared for appropriately in hospital. In order to manufacturer the large numbers required, innovative methods of regulation had to be developed, which resulted in the ‘Ventilator Challenge’, where regulators, clinicians, conformity assessment bodies, and industry worked together to produce appropriate ventilators in short order. There was no doubt, that this co-operation and collaboration quickly and efficiently identified and resolved issues, leading to the manufacture of nearly 40,000 devices, without compromising patient safety. These lessons are being well applied now that the initial challenge
of the pandemic has subsided somewhat, with the MHRA keen to engage with those who they regulate, to develop a regulatory system which ultimately, will be world leading. Interactions with industry and wider stakeholders is seen as vital to the appropriateness of regulation for a number of reasons:
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Scan here 28 UKHEALTHCARE P A VILION. COM DUSSELDORF 2022
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