Part three of the design verification series discusses in detail the steps that should be taken during testing.
Prior to design verification of packaged products, consider the following process-related elements.
The way in which we deliver healthcare is changing rapidly. Technology and rapid adoption is enabling device and tech manufacturers to develop products that move the delivery of care away from the clinical environment. Having the option to stay out of hospitals could be extremely important from both a financial standpoint as well as a health perspective, and could essentially help low-risk patients avoid exposure to viruses. Our experts today provide information regarding the regulatory requirements for …
This week’s guidance is all about the manufacturing control of sterile medical devices, validation, and more validation.