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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

Complaints and MDRs and Recalls, Oh My!

Complaints and MDRs and Recalls, Oh My!

Author: Rachel Benway, Product Manager, Reed Tech It was a rainy couple days in Washington, DC for the Complaints, MDRs, & Recalls Workshop hosted by AdvaMed on February 11th and 12th but that didn’t stop people from all over the world from gathering to discuss...

Voluntary Adverse Event Reporting-Get Alerts

Voluntary Adverse Event Reporting-Get Alerts

Author: Haley Lentz, Senior Sales Manager, Life Sciences Several years ago, our team met with a medical device manufacturer to review the safety and quality profile for one of their devices. During the review, the individual noticed a device problem they had not...

The Modernization of 510(k) and Ineligible Predicates

The Modernization of 510(k) and Ineligible Predicates

Author: Rachel Benway, Product Manager, Reed Tech The FDA has placed increased attention on the 510(k) Clearance pathway over the past couple of years which included publishing multiple press announcements from FDA Commissioner Scott Gottlieb and CDRH Director Jeff...

Medical Device Recalls-An Industry Snapshot

Medical Device Recalls-An Industry Snapshot

Author: Rachel Benway, Product Manager Reed Tech Since 2016, Reed Tech has been designing and curating the Navigator™ for Medical Devices database. At this point, it is a vast and rich source of medical device data. Using this database, we were able to run some...

Webinar Recording: Predicting Medical Device Recalls

Webinar Recording: Predicting Medical Device Recalls

Is predicting medical device recalls possible? In this presentation, we review some compelling research that indicates-yes! Did you know? We have been designing and curating an expansive database of medical device companies and products since 2016. Review an overview...

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...

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...

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