Compliance
The 6 Most Common Inspection Failures and Why They Happen
The quality control process consists of different phases, each dependent on the industry, type, and size of the business. However, there is a general rule…
3 Approaches to Get You Moving on UDI Implementation
September 24 has become a date that inspires anxiety among medical device manufacturers. September 24, 2014 was the UDI (unique device identifier) compliance deadline for…
Are You Feeling the Pain of UDI Implementation?
Are You Feeling the Pain of UDI Implementation?
Jul 07 2016
The current regulations are the result of a final rule released in September of 2013 by the FDA, which stipulated that most medical devices carry…
How FDA Mandate on UDIs Will Impact Medical Device Manufacturing
All devices as defined by 21 USC 321 (h), i.e., a “medical device,” are subject to the requirements of the UDI rule unless an exception…