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Volume 13 Issue No. 16 |
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By Adrian Pittman, Google; Devices by themselves don’t improve outcomes. Better lifestyle integration is key to driving changes in patient compliance—embedding sensors into the sorts of devices people can use every day to increase opportunities for passive biometric capture and to facilitate therapeutics. |
| Featured Articles |
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CDRH Reflects One Year into Pandemic, By MedTech Intelligence Staff The center is working to address the delays in meeting review timelines for product submissions. |
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MEDdesign FDA Introduces the Safer Technologies Program for Medical Devices By Tara Lysechko, Starfish Medical The program highlights the agency’s commitment to improving safety and supporting innovation, and is a welcome counterpart to the Breakthrough Devices Program. |
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CareFusion Alaris Recall Affects More than 145,000 Pumps By MedTech Intelligence Staff A product issue could cause keys to become unresponsive or stuck, leading to infusion delays. |
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Contract profitability requires real-time visibility into assets so manufacturers can make decisions proactively rather than reactively and maintain customer excellence. |
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Understanding the cost to service by product and by subcomponent will help you identify which service events are the most impactful to the bottom-line financials of the business. |
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SPONSORED CONTENT |
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A discussion with Geoff Wood about the advantages offered by having a pre-assessment before a Stage 1 and 2 Initial Audit. |
Ask the Expert:|
Featured Quote — Steeve Huin, Irdeto |
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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 (On-Demand Recording) April 6, 2021: Quality Processes and Documentation April 13, 2021: Clinical Evidence & Surveillance (On-Demand Recording) April 20, 2021: Supply Chain Management: Economic Operators, UDI, and Labeling (On-Demand Recording) April 27, 2021: Strategy and Planning |
| MedTech Library |
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Sponsored By S3 Connected Health Connectivity is now a must when designing or redesigning in-hospital medical equipment. Data insights collected on connected medical devices can bring many benefits for vendors, healthcare providers, and patients; from improving healthcare outcomes to reducing the cost of care and device maintenance. This whitepaper details the key steps to consider when creating a secure, scalable connectivity ecosystem based around medical equipment in the hospital environment. |
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The Business Value of Cybersecurity in MedTech Sponsored By Irdeto |
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MDR Documentation Submissions: Best Practices Guidelines Sponsored By bsi. |
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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 |
How to create scalable connectivity ecosystems for in-hospital medical equipment
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