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

Electronic Drug Listing and Registration Guides

Electronic Drug Listing and Registration Guides

To learn the main requirements for Electronic Drug Registration and Labeling (eDRL), download a quick-reference guide with step-by-step instructions and ways to simplify and expedite the process. Download your free guide here. The eDRL How-to Guide answers questions...

UDI Labeling (Unique Device Identification): Best Practices

UDI Labeling (Unique Device Identification): Best Practices

Unique Device Identification (UDI) labeling remains a hot topic among medical device manufacturers under pressure to comply with UDI requirements for US FDA GUDID and other emerging health authorities around the globe. EU EUDAMED is underway and China’s NMPA,...

Update: EUDAMED Actor Module Now Planned for December 2020

Update: EUDAMED Actor Module Now Planned for December 2020

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...

UDI and 21 CFR Part 11

UDI and 21 CFR Part 11

Medical device manufacturers working to comply with the FDA’s Unique Device Identification mandate have more than one set of regulations to keep in mind. Fortunately, some of the regulations have been in place for some time and will be at least somewhat familiar to...

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...

How does a Medical Device Product Data Pool Work?

How does a Medical Device Product Data Pool Work?

Why your product data needs to be in GDSN…NOW! If you manufacture medical devices, you know the challenges in managing accurate, current, and complete product data and sharing it with your trading partners. Your data consumers, both internal and external, trust your...

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....

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