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…
Compliance
Navigate regulatory requirements for converting and packaging equipment. Delta ModTech’s guide to compliance standards and validation processes.
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…
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…
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…