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Medical Device Safety and Quality

Medical Device Safety and Quality

Medical Device Safety and Quality

How to bring your 510(k) Research into the 21st Century

Evaluating Medical Device Safety and Quality with Data Analytics

Reed Tech Navigator™ for Medical Devices

Meet the Team-Erin McDermott

Meet the Team-Erin McDermott

Meet the Team at Reed Tech Erin McDermott, Account Executive, Medical Devices   Q: What can you tell us about your current role? A: My current role at Reed Tech is a hybrid position supporting Navigator for Medical Devices across all territories. I support anyone...

The 7 core elements of ISO 14971

The 7 core elements of ISO 14971

Risk Management for the Medical Device Industry: What is ISO 14971? ISO 14971 is an International standard that describes a systematic approach for medical device risk management. ISO 14971 has been recognized as a consensus standard by most regulatory agencies around...

Happy New Year! Holiday Schedule

Happy New Year! Holiday Schedule

Due to the impending December 31 deadline for Establishment Registration and Blanket No Change Certification submissions, we are currently processing an extremely high volume of SPL conversion orders. Accordingly, to guarantee delivery by December 31, we must receive...

510(k) and Medical Device Safety News

510(k) and Medical Device Safety News

Ongoing media attention concerning medical device safety and quality is causing many to question whether there is a need to reform the 510(k) clearance process. Nearly 20% of current 510(k)s are cleared based on predicates that are more than 10 years old, according to...

All Along the Watchlist — Product Alerts

All Along the Watchlist — Product Alerts

If you monitor medical device products, that can mean waiting to receive notifications from the FDA or other entities to surface news about reported problems or recalls. With Reed Tech Navigator™ for Medical Devices, users can activate Product Alerts to receive email...

Zoom In: A Closer Look at Device Safety Data

Zoom In: A Closer Look at Device Safety Data

In our last post, we discussed how the media, Congress and the FDA is paying increased attention in recent years to medical device safety. We highlighted the cost to the device industry of FDA enforcement actions (Reed Tech estimates $4 billion per year). We also...

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