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Advising LetsGetChecked on all areas of EU regulatory compliance, particularly under the IVDR, regarding the provision of their at-home test kits and services.
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Acting as EU regulatory counsel to Fitbit LLC (now Google LLC) supporting EU regulatory compliance programmes for EU consumer products and medical devices frameworks.
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Provided EU product regulatory advice to Google LLC during the development and launch of its Loss of Pulse Detection device.
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Advising Nest Labs (now Google LLC) on compliance with EU regulatory frameworks applicable to various general consumer and health & wellness products.
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Advising a Fortune 100 healthcare company on the classification of its portfolio of software medical device applications in the EU and the UK.
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Advising a Fortune 100 healthcare company on their QMS structure and delegation of certain compliance activities under a quality agreement.
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Advising a global telemedicine business on the application of EU prescription and control of supply requirements to its operating model.
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Advising a global pharmaceutical company on its obligations around interactions with HCPs in Ireland as part of planned promotional activities.
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Advising a US manufacturer of a surgical device responding to an investigation by the Health Products Regulatory Authority (HPRA).
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Advising a manufacturer of CBD products responding to a regulatory investigation and enforcement measures carried out by the Food Safety Authority of Ireland (FSAI).
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Acting as EU regulatory counsel to a global diabetes treatment company. Our work involves providing support on EU regulatory requirements for various software medical devices, connected insulin pump devices and related accessories.
