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Volume 13 Issue No. 08 |
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By Joe Muldoon, FAST BioMedical We have the opportunity to refine processes that were implemented in a hurry during the pandemic, along with the insight to improve the entire healthcare system. |
| Featured Articles |
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Rice University Gets Up to $1 Million to Develop Sensor that Detects Airborne COVID-19 By MedTech Intelligence Staff The real-time bioaerosol sampling system can detect a very low concentration of SARS-CoV-2 in the air. |
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President Biden Nominates Chiquita Brooks-LaSure By MedTech Intelligence Staff Brooks-LaSure has more than two decades of experience in health policy and played a crucial part in the passage of the Affordable Care Act. |
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SPONSORED RESOURCE |
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This 1-day #LiveOnline #training #course clarifies #ISO13485:2016 requirements and interpretations. Organizations that need to show evidence that they can provide medical devices, which consistently meet customer and regulatory requirements, will benefit from understanding ISO 13485. A must for those, who will be auditing their own organizations. |
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MEDdesign Avoiding FDA Enforcement Actions: Understanding Quality Systems By Amy Scanlin, EAS Consulting Group, LLC The greatest challenge faced is an understanding of the intent of the written regulations and applying them correctly. |
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Soapbox Future of Specialty Telemedicine By Jonathan Wiesen, M.D., MediOrbus Its success lies in a synergy between the technological and the clinical. |
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More Cyberattacks in Healthcare, Yet Most MedTech Leaders Unprepared, Says Survey By MedTech Intelligence Staff A mere 13% of IoMT leaders believe their organization is in a good place to mitigate future risks related to cybersecurity. |
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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 |
| 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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