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?
Your first step should be contacting our Regulatory Experts!
We are here to be your Regulatory Risk Partners for Medical Devices, Diagnostics and Digital Health!
Our experts have robust experience of cutting through the maze and navigating regulatory affairs for your medical innovation.
Send us an email at mdd@mddltd.com and get a FREE 30 Minute Consultation with our experts!
