FDA Investigating More than 450 MDRs Related to Endoscope Reprocessing By MedTech Intelligence Staff The medical device reports describe both patient infections and other possible contamination issues. |
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MEDdesign Lessons Learned: By Josh Turpen, Jama Software It’s time to take stock on what temporary measures need to be made permanent to grow as an industry. |
By MedTech Intelligence Staff Companies within the life sciences industry should rethink how they manage their data and documents. |
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Ask the Expert: A discussion with Geoff Wood about the advantages offered by having a pre-assessment before a Stage 1 and 2 Initial Audit. |
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The Business Value of Cybersecurity in MedTech 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. |
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. |
Soapbox Regulatory Information Management Streamlines Processes and Supports Data Quality By Romuald Braun, Amplexor Data integration is doing much to enhance regulatory information management. Life sciences companies are increasingly discovering useful interdependencies between data, documents and RIM processes. The next step is to put this data to work to improve efficiency. |
Featured Quote — Beth Peckover, Kallik |
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COMPLIMENTARY |
EU IVDR - Process, Data, Reporting & Planning 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 April 20, 2021: Supply Chain Management: Economic Operators, UDI, and Labeling April 27, 2021: Strategy and Planning |
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How to create scalable connectivity ecosystems for in-hospital medical equipment 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. |
The Business Value of Cybersecurity in MedTech Sponsored By Irdeto |
MDR Documentation Submissions: Best Practices Guidelines Sponsored By bsi. |
Explaining IVD Classification Issues Sponsored By bsi. |
Telemedicine Cybersecurity Report: Android Patient-Facing Mobile Apps Sponsored By Irdeto |
Unlocking Medtech’s Future Potential with Connected Devices and Services Sponsored By S3 Connected Health |
How to optimize coatings and substrates for compatible medical devices Sponsored By KRÜSS |
Securing devices so that clinicians and patients connect without fear. Sponsored By Irdeto |
Telemedicine Cybersecurity Report: iOS Patient-Facing Mobile Apps Sponsored By Irdeto |
The engineer’s guide to wearables Sponsored By 3M |
The Growing Need for Real-World Evidence in Medical Devices Sponsored By Evidera |
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