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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

Expedited Assistance for Regulatory Compliance Related to COVID-19

Expedited Assistance for Regulatory Compliance Related to COVID-19

Many organizations are stepping up to innovate and transform their operations to implement goods and services needed in the battle against COVID-19. Reed Tech stands ready to help and is making mitigation of COVID-19 a priority. We remain fully operational to assist...

Balance Medical Device Risk Analysis with Internal & External Data

Balance Medical Device Risk Analysis with Internal & External Data

Author: Rachel Benway, Product Manager Last month we held a webinar on the updates to ISO 14971 published fall of 2019 and the importance of using post-market data as part of any risk analysis process.  Throughout the webinar, we performed several polls and learned...

510(k) Streamlining and Lessons Learned

510(k) Streamlining and Lessons Learned

Author: Erin McDermott, Account Manager Life Sciences Attending a Virtual Conference As is the rest of the world, the MDMA FDA 2020 Forum seemed to be in a place of uncertainty leading up to its scheduled occurrence last Thursday & Friday in Palo Alto, CA....

510(k)s Make the Medical Device World Go Round

510(k)s Make the Medical Device World Go Round

Authors: Haley Lentz, Sales Manager & Rachel Benway, Product Manager, Reed Tech The medical device industry is constantly innovating new ways to treat patients in settings ranging from acute surgical care, to outpatient health centers and to home use. Of course,...

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...

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 medical devices — 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 the...

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