Judith Koehnen, Director, Project Management, Medical Device and Diagnostics, Author at Insights From Our Labs to Yours

ISO 14155 update: key risk management changes for medical device clinical investigations in 2019

byJudith Koehnen, Director, Project Management, Medical Device and Diagnostics updated onTuesday, June 2, 2020Monday, April 15, 2019

ISO 14155标准的第三版for medical device clinical investigations is expected to be published in 2019. It could be published as early as this spring and probably arrive no later than mid-year. According to the International Organization for Standards (ISO), the updated edition will focus on …

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How a no-deal Brexit might affect medical device development: legal consequences and risk mitigation strategies

byJudith Koehnen, Director, Project Management, Medical Device and Diagnostics updated onTuesday, June 2, 2020Thursday, February 21, 2019

How could a no-deal Brexit affect my medical device lifecycle? Considerable uncertainty surrounds Britain’s imminent exit from the EU, and it is possible that there could be a “no-deal Brexit” scenario. The full implications are still unclear, however it is a stressful time for UK manufacturers and sponsors of medical …