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Medical Technology and ESG: Solving the Data Problem In a recent State of ESG In Manufacturing survey, just one third (31%) of respondents reported high confidence in the quality and accuracy of their organization’s supply chain data. That lack of confidence is a harbinger of risks to come, as low confidence in data means …
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What You Need To Know About FDA Remote Medical Device Inspections Back in 2021, I wrote that FDA should have the authority to inspect medical device facilities remotely. This would allow FDA to check these facilities when in‑person inspections weren’t possible. The remote inspection argument was especially compelling in the throes of Covid-19, which …
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FDA To Host Webinar on Electromagnetic Compatibility of In Vitro Diagnostic Devices The FDA is hosting a webinar on February 2 from 1:00-2:00pm ET for interested stakeholders to discuss the final guidance Electromagnetic Compatibility (EMC) of Medical Devices and its applicability to in vitro diagnostic (IVD) devices. The FDA announced that during this webinar it …
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FDA Issues Final Guidance on “Device” and “Counterfeit Device” Definitions The FDA has issued the final guidance: Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents. The guidance is intended to clarify the FDA’s approach for referencing the terms “device” and “counterfeit device” …
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Preparing for a Data-first Regulatory World Even in today’s eCTD world, most life sciences regulatory teams still think and work in terms of documents, paragraphs and sentences when putting together collateral for marketing authorization and variations submissions. Yet it is data, rather than pre-prepared dossiers, that are moving into central focus now. Stakeholders across …
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