This site uses modern web standards that aren't supported by your browser. For best results, please upgrade to Google Chrome, Microsoft Edge, or Mozilla Firefox.

Life Sciences

Life Sciences

Update: EUDAMED Actor Module Delayed to 2021 March

Update: EUDAMED Actor Module Delayed to 2021 March

EU EUDAMED Update Updates continue to be issued from both the European Commission and industry concerning EUDAMED in light of the current COVID-19 pandemic. The latest information sets new expectations about the availability of modules and expected activity. The...

Fact vs Fiction: GDSN Connection

Fact vs Fiction: GDSN Connection

Author: John Lorenc, Sr. Manager Regulatory Solutions, Reed Tech Fiction:  Most global health authorities subscribe to a GDSN data pool, therefore, UDI compliance can be achieved by a standard GDSN data pool publication. Fact:  One of the largest health authorities,...

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....

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 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...

By continuing to use the site, you agree to the use of cookies. more information

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.

Close