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Life Sciences

Life Sciences

Your Response to the FDA Class I Medical Device UDI Delay

Your Response to the FDA Class I Medical Device UDI Delay

Update on FDA Class I UDI On July 1, 2020 the U.S. Food and Drug Administration (FDA) issued a Guidance document for labelers of Class I medical devices. In an effort to help the industry remain focused on high quality Unique Device Identification (UDI) submissions...

Fact vs Fiction: UDI in China and Global Data Pools

Fact vs Fiction: UDI in China and Global Data Pools

Introduction The National Medical Products Administration (NMPA) is the regulating body in China for drugs and medical devices. The NMPA is the authoritative group that drafts laws and regulations for drugs, medical devices, and cosmetics. They also establish medical...

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...

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