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Volume 13 Issue No. 21 |
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MEDdesign
By Kim Wakeman, EtQ As the pace of innovation further accelerates in 2021, and the need to get new devices to market intensifies, maintaining adherence to regulatory controls is not enough. |
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SPONSORED RESOURCE |
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The video revolution has come to medical device assembly. Here are the top six ways leading Class II/III device manufacturers are using video to transform the effectiveness of everyone on and around the line — including the line operators themselves. |
Top 6 uses for video on medical device assembly lines| Featured Articles |
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Boston Scientific Recalls Venous Stent System Due Device Migration By MedTech Intelligence Staff Nearly 32,000 stent systems have been recalled in the United States. |
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Patient Engagement and Connected Medical Devices Series: By Adrian Pittman, LinkedIn; Bernhard Kappe and Randy Horton, Orthogonal 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. |
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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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AI in Healthcare to Reinforce Drug Discovery and MedTech Applications By Saloni Walimbe, Global Market Insights During the COVID-19 crisis, digital forces like artificial intelligence have assisted the healthcare industry to focus on patient care while achieving improved efficiency during treatments. |
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SPONSORED RESOURCE |
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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. |
How medical device companies can create end-to-end connectivity for in-hospital equipment|
Featured Quote — Louis Lehot, Foley Lardner |
| MedTech Library | |
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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. Recorded March 30, 2021: EU IVDR Introduction Recorded April 6, 2021: Quality Processes and Documentation Recorded April 13, 2021: Clinical Evidence & Surveillance Recorded April 20, 2021: Supply Chain Management: Economic Operators, UDI, and Labeling Recorded April 27, 2021: Strategy and Planning |
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