This should be one of the first questions asked during the medical device development process.
Category Archives: Design Control
Europe MDR General Safety & Performance Requirements vs. MDD Essential Requirements
The Annex I “Essential Requirements” of the European medical device directives have been supercharged and reincarnated
ASTM F1980 Accelerated Aging Calculator
Accelerated Aging is utilized to establish the shelf life of a product relatively quickly.
Damn…we failed verification testing!
I can think of 3 options when engineering specification (design verification spec) is not met.