The next series of “facts” is about Design requirements.
The FDA requires all Class II or III medical device manufacturers to prove that they have control over their design process. Design controls provide evidence that there has been a method employed during the product development stage. The intent is to have a system in place that will create a device that is both safe for the public to use and that produces the desired result. Minimally, these controls must contain:
- Identification of the intended use and requirements
- A design plan
- Periodic design reviews throughout the design process
- Confirmation that the design outputs conform to the design inputs through:
- Design verification
- Design validation
- Creation of specifications to move to the manufacturing process
- Complete documentation of the entire process in a Design History File (DHF)
Section 7.3 of ISO 13485 identifies which Standard Operating Procedures need to be in place in order to comply with Quality System requirements for all steps related to the design process. These include: Design Input, Design Output, Design Review, Design Validation, Design Verification, Design Transfer, Design Change, and Design History File.