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Life Sciences

Life Sciences

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....

COVID-19 Resources

COVID-19 Resources

As the impact of the novel coronavirus virus (COVID-19) unfolds, all of us are being challenged with adapting to new ways of working and living. We are all adjusting to social distancing, remote workplaces and restricted travel. Like many other businesses around the...

Global UDI Data Management-5 Best Practices

Global UDI Data Management-5 Best Practices

For Unique Device Identification (UDI) data management, there are some basics that medical device manufacturers should always keep top of mind. Here’s a 3 minute run-down of Five Best Practices for Global UDI Data Management.  For more information, see the...

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...

The National Drug Code (NDC) 10 & 11 Digit Format

The National Drug Code (NDC) 10 & 11 Digit Format

Per the Drug Listing Act of 1972, part of the Food and Drug Administration (FDA) requirement to electronically list drug products (Rx and OTC) includes the assignment of a National Drug Code (NDC). An NDC is a 10 digit number that uniquely and universally identifies a...

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...

Survey Shows Most Are Continuing Preparation for EU EUDAMED

Survey Shows Most Are Continuing Preparation for EU EUDAMED

Author: Gary Saner, Sr. Manager Information Solutions, Reed Tech   Survey Results Are you as a medical device manufacturer, in the middle of preparing for the EU Medical Device Regulation (MDR) and trying to figure out your response to the European Commission’s...

Webinar Recording: Prepare for EU and Other Global Regulators

Webinar Recording: Prepare for EU and Other Global Regulators

RAPS (Regulatory Affairs Professionals Society) hosts as Reed Tech shares their expertise on the topic of ‘Prepare for EU & Other Global Regulators’.  On the agenda: The known requirements of emerging regulatory channels and commercial UDI adopters...

EU EUDAMED Delayed-What to do now

EU EUDAMED Delayed-What to do now

Author: Gary Saner, Sr Manager Information Solutions, Reed Tech The speculation on EUDAMED timing has been addressed by the European Commission’s (EC) announcement on 30 October 2019 that EUDAMED will be delayed two years from the original date of 26 May 2020 to 26...

FDA GUDID Class I Reminder

FDA GUDID Class I Reminder

What are the requirements for Class I medical devices concerning unique device identification (UDI) data submission to US FDA GUDID?  Class I devices, and devices that have not been classified into class I, class II or class III that are required to be labeled with a...

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