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Volume 13 Issue No. 09 |
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By Adrian Pittman, Google; Bernhard Kappe and Randy Horton, Orthogonal In this series we examine the future of the medical device industry—from manufacturing to the consumer-patient experience. |
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SPONSORED RESOURCE |
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Sponsored By Irdeto Build a secure line of defense for your devices against a growing range of cyberattacks. Irdeto's report in collaboration with Censuswide has identified clear ways for Health companies to improve customer and patient outcomes, make better data-driven decisions, increase trust, and generate more revenue. |
The Business Value of Cybersecurity in MedTech| Featured Articles |
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Medtronic Recalls HVAD Pump Implant Kits for Product Failure By MedTech Intelligence Staff There have been 29 complaints, including 19 serious injuries and two deaths, related to the device issue. |
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FDA Authorizes New Device that Protects the Brain From Head Hits By MedTech Intelligence Staff The Q-Collar uses jugular compression to help protect an athlete’s brain from the effects of repetitive head impacts. |
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By Donna Morrow, Noteworth As restrictions lift and in-person visits become viable again, the use of virtual care technology — particularly telemedicine and remote patient monitoring (RPM)—is here to stay. |
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Soapbox Medical Devices: Is There Life After Death? 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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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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Featured Quote — Jennifer S. Geetter, McDermott Will & Emery |
| 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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The Business Value of Cybersecurity in MedTech Sponsored By Irdeto |
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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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