Medical Innovation Exchange

regulatory

FDA To Host Webinar on Electromagnetic Compatibility of In Vitro Diagnostic Devices

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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European Commission Proposes Extended Timeline for EU MDR/IVDR Compliance  

European Commission Proposes Extended Timeline for EU MDR/IVDR Compliance       On January 6, the European Commission adopted a proposal to give more time to certify medical devices under EU MDR to mitigate the risk of shortages. The proposal now needs to be adopted by the European Parliament and the Council. The proposal introduces a …

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Critical Manufacturing Partners with Dataworks To Enhance CSA Support

Critical Manufacturing Partners with Dataworks To Enhance CSA Support     Critical Manufacturing, developer of multi-site manufacturing execution systems (MES), has entered into a strategic partnership with Dataworks, a provider of software solutions and validation services for the Life Sciences sector. “Dataworks focuses on the provision of transformational software solutions and validation services within the Life …

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RQM+ Acquires Jordi Labs

RQM+ Acquires Jordi Labs     RQM+, a provider of regulatory, quality, clinical and laboratory services for the MedTech industry, and Linden Capital Partners, a Chicago-based private equity firm focused exclusively on the healthcare industry, have acquired Jordi Labs. Jordi Labs provides chemical characterization and complex product deformulation as well as contaminant and failure investigations to …

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Streamlining the Literature Review Process

Streamlining the Literature Review Process     Literature reviews play an integral role in the regulation of medical devices and technologies. We spoke with Evidence Partners’ CEO Peter O’Blenis to learn more about the challenges of literature reviews, their role in supporting patient safety and global regulatory approval, as well as new tools that help medtech …

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