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Life Sciences

Life Sciences

The 7 core elements of ISO 14971

Risk Management for the Medical Device Industry: 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...

Does UDI matter when it comes to Reimbursements?

Is your supply chain process prepared for reimbursement scenarios? Traditional Class I, II, III medical devices and even some ‘specialty’ accessories (like unique packaging mechanisms) need a product data management strategy that includes reimbursement considerations...

What is a GLN (Global Location Number)?

Global Location Number (GLN) How does the supply chain keep ‘order’ in identifying locations and functions? The identifying key to determine the ‘where’–physical/digital location and the ‘who’—a function and or legal entity is the GLN. Global Location Number...

Reed Tech Insights – UDI and Class I Medical Devices

Reed Tech presented at the recent Pharma and Device Packaging and Labeling West Coast Conference in Burlingame, California. To see some quick insights, download the slides on Placing UDI on Class I Medical Device Labels and Reporting UDI Data to the FDA GUDID by...

Happy New Year! Holiday Schedule

Due to the impending December 31 deadline for Establishment Registration and Blanket No Change Certification submissions, we are currently processing an extremely high volume of SPL conversion orders. Accordingly, to guarantee delivery by December 31, we must receive...

510(k) and Medical Device Safety News

Ongoing media attention concerning medical device safety and quality is causing many to question whether there is a need to reform the 510(k) clearance process. Nearly 20% of current 510(k)s are cleared based on predicates that are more than 10 years old, according to...

Increase Your Corporate Value by Providing Product Data via GDSN

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...

Video: Medical Device Industry Trends & Timelines

What trends are expected with Global Regulator UDI activity and anticipated timelines? Listen to a short excerpt on medical device industry trends and timelines from the recent webinar: From UDI to GDSN-Are You Ready?   Questions about how to put your UDI data to...

Webinar: From UDI to GDSN-Are You Ready?

Listen to medical device data experts from Reed Tech to learn about the benefits of putting your UDI to practical use and the importance of preparing your data now for GDSN and anticipated commercial data exchange requirements. Learn how a manufacturer can pivot from...

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