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Volume 13 Issue No. 04 |
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By Melanie J. Haga, Back Thru The Future Regardless of the reason for disposing of a medical device or other electronic equipment, the product must be destroyed in a manner in which it can never be reused or identified as coming from your organization. In addition, the resulting materials from the destruction process be disposed of in an environmentally appropriate and regulatory compliant manner. |
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SPONSORED RESOURCE |
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Sponsored By S3 Connected Health Demand for hospitals to operate at peak efficiency is driving demand for services based around connected devices. Adding connectivity to devices and becoming a service provider can be challenging. |
| Featured Articles |
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Regulatory Information Management Streamlines Processes and Supports Data Quality By Romuald Braun, Amplexor Data integration is doing much to enhance regulatory information management. Life sciences companies are increasingly discovering useful interdependencies between data, documents and RIM processes. The next step is to put this data to work to improve efficiency. |
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By MedTech Intelligence Staff The deal involves an upfront cash payment of $925 million, followed by a potential $300 million commercial milestone payment. |
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COMPLIMENTARY |
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COMPLIMENTARY Virtual Events The European In Vitro Diagnostic Regulation (EU IVDR) will profoundly affect the global diagnostics market, requiring new procedures, evidence development, documentation, organizational structures, data management, reporting, and a reassessment of legacy portfolios. Preparation will involve strategic thinking and buy-in at the highest levels. Implementation of IVDR is scheduled for May 2022, with no indication that it will be deferred. For those who have not already begun planning for the change, it is urgent to begin now or face exclusion from the European market. March 30, 2021: EU IVDR Introduction April 6, 2021: Quality Processes and Documentation April 13, 2021: Clinical Evidence & Surveillance April 20, 2021: Supply Chain Management: Economic Operators, UDI, and Labeling April 27, 2021: Strategy and Planning |
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Returning to ‘Normal’: By Shady Hassan, M.D., Vocalis Health A return to normalcy requires us to address the limits of current testing approaches and broadly deploy reliable screening tools that facilitate early detection and encourage more focused testing of those at high-risk of spreading the coronavirus. |
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Quality Considerations for Drug-Device Combination Products By Amy Scanlin, EAS Consulting Group, Inc. Understanding the GMP requirements of each component is critical to product and compliance success. |
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SPONSORED RESOURCE |
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Sponsored By KRÜSS Taking a close look at coatings, substrates, and surface preparation helps not only develop ground-breaking materials, but also enhances how well existing liquids and solids work together. |
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FDA Commissioner Hahn Departs, Encourages Staff to By Maria Fontanazza, Editor-in-Chief Following a dramatic but brief tenure as commissioner, Stephen Hahn, M.D. used Twitter to leave his departing remarks on the morning of the inauguration. |
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CDER Director Janet Woodcock to Serve as Interim FDA Commissioner By MedTech Intelligence Staff Woodcock was selected by outgoing Commissioner Stephen Hahn, M.D. |
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SPONSORED RESOURCE |
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In this new whitepaper, Irdeto identified five B2C patient-facing Android telemedicine mobile apps that offer both synchronous and asynchronous virtual visit experiences to US consumers and are downloadable via Google Play and performed an extensive cybersecurity threat risk analysis of these apps. |
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Featured Quote — Caroline Loew, Ph.D., Glympse Bio |
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| MedTech Library |
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Telemedicine Cybersecurity Report: Android Patient-Facing Mobile Apps Sponsored By Irdeto |
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Unlocking Medtech’s Future Potential with Connected Devices and Services Sponsored By S3 Connected Health |
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How to optimize coatings and substrates for compatible medical devices Sponsored By KRÜSS |
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Securing devices so that clinicians and patients connect without fear. Sponsored By Irdeto |
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Telemedicine Cybersecurity Report: iOS Patient-Facing Mobile Apps Sponsored By Irdeto |
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The engineer’s guide to wearables Sponsored By 3M |
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The Growing Need for Real-World Evidence in Medical Devices Sponsored By Evidera |
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