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.
In the world of medical device manufacturing, mistakes on the plant floor can have dire consequences. That’s why meeting FDA requirements such as 21 CFR Part 820, 21 CFR Part 11 and ISO 13485 are so critical.
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.
Recently, I was involved in a sales call with a major medical device manufacturer. While exchanging goodbyes, the EVP said, “This implementation has to work.” For prospective buyers those words seem to be all too common.
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.