Category: Medical Device

Blog Post

3 Ways the Digital Enterprise Can Better Navigate Uncertainty in Today’s ...

As the world fights the coronavirus, it is quickly becoming evident that “business as usual” no longer applies. New business models will be evaluated, and massive “pivots” may be needed to meet the evolving needs of our society. The Digital Enterprise is best poised to be part of the new “non-normal” environment we now operate in.
Blog Post

The Impact of ISO 13485

The publication of the ISO 13485:2016 standard in March of this year realizes work that began in July 2014 with the rejection of the first Draft International Standard (DIS)
Blog Post

Waiting for an eDHR Mandate? Best-in-Class Medical Device Manufacturers ...

In today’s highly competitive, fast-paced medical and diagnostic device industry, manufacturer’s often struggle to find the right time to shift away from their costly, inefficient and error-prone processes, such as assembling a DHR (Device History Record) from multiple paper and spreadsheet sources.
Aerospace & Defense

What is Complex Discrete Manufacturing?

Complex discrete manufacturing industries manufacture complex highly engineered products with longer product cycle times and multiple levels of subassemblies in their bills of material.
Blog Post

New Acronyms from the FDA: UDI and GUDID

On September 24, 2013, the FDA established a Unique Device Identification (UDI) system to identify all medical devices sold in the U.S. starting from the point of manufacture, through all distribution channels, and to the eventual sale to the consumer.
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