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Volume 13 Issue No. 07 |
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By MedTech Intelligence Staff The record-high number of authorizations last year was a significant jump over 2019. |
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Soapbox How Hospitals and Health Systems Can Accelerate Innovation By Kristian A. Werling, McDermott Will & Emery Among the many lessons from the COVID-19 pandemic, it’s clear that the future of healthcare belongs to those who can harness science and technology—sometimes rapidly—to improve population health through more efficient and accessible care. |
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Innovations in Self-Monitoring Blood Glucose Devices Will Impact Healthcare Services By Sunil Jha, Global Market Insights Seamless and personalized diabetes care has become a new normal. |
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Soapbox How Life Sciences Companies Can Level Up Healthcare Education in Post-COVID Era By Parth Khanna, ACTO It’s time for these companies to bridge the knowledge gap and transform how healthcare information is accessed and used. |
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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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COVID-19 Introduces New Risks, Hazards in Health Tech By MedTech Intelligence Staff With the accelerated adoption of many new technologies, ECRI’s annual health technology hazards list has been transformed by the COVID-19 pandemic. |
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CAPA Corner Why You Must Have a Single Source of Truth for CAPA By Jon Speer, Greenlight Guru CAPA consistently remains a top reason for FDA’s 483 observations, usually due to inadequate processes or inconsistent adherence to regulatory requirements. |
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MEDdesign The New Way of Healthcare with Additive Manufacturing By Christopher Cho, nTopology Disruptions in the traditional manufacturing supply chains made the world realize the benefits of additive manufacturing. In this article, we will focus on the development of this practice and the diverse ways it has been applied in the medical industry—from COVID-19 swabs to orthopedic implants. |
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Featured Quote — Dan Fowler, WuXi AppTec |
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| MedTech Library |
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Sponsored By bsi. The two most frequent reasons for delays to technical documentation reviews are:
To reduce the frequency of the above issues, BSI Medical Devices Group proposes this guidance, informally known as “MDR Documentation Submissions: Best Practices Guideline." |
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Explaining IVD Classification Issues Sponsored By bsi. |
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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 |
MDR Documentation Submissions: Best Practices Guidelines
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