Did you notice that the published regulation does not have a table of contents or bookmarks?
Does your organization’s Quality Policy inspire you, or tire you? Are you Quality Objectives follow a framework established by the Policy statement?
Still trying to figure out what to do about EN ISO 14971:2012?
Before you read the vocabulary definitions in ISO 9000:2015 you need to know what the “small words” mean.
Accelerated Aging is utilized to establish the shelf life of a product relatively quickly.
I can think of 3 options when engineering specification (design verification spec) is not met.