Design File Compilation
What is a Design File for a medical device?
Design files are crucial documents that need to be submitted by the manufacturer to a Notified Body for approval. There are regulatory and legal requirements for submitting these files. One of the essential elements of the design file is - A Design History File (DHF). DHF stores all documentation related to design controls. It indicates the design history of a medical device and provides evidence that all design control procedures were implemented correctly and followed by the manufacturer. This is a mandatory requirement for regulatory agencies (FDA 21 CFR 820 and ISO 13486).
Here is a list of all the documentation that should be included in your Design History File:
- Design and development planning
- Design input - procedures for establishing design input and the approved documentation
- Design output - procedure for defining and documenting design output and the approved documentation
- Design review - procedure for conducting reviews of the design process
- Design verification – documentation describing the design validation process
- Design validation – documentation of the procedure and testing conditions used for design validation
- Design changes - include the documented design change process
Are your files ready?
Or are you wondering where to start from?
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