The launch of a new medical device is a time of great excitement. After all, you’re creating something that could potentially improve or even save lives. While the documentation of a new medical device isn’t quite so exhilarating, it’s crucial to your success.
Creating a Design History File (DHF) for each device is a critical component of your medical device enterprise. It provides proof to the FDA that you followed all Design Control regulations. Even after your device receives market clearance, the FDA may audit you, so you must have this documentation in order. An effective Design History File includes:
- Your Design Controls
- The relationships between and among them
- Clear traceability of these relationships
- Thorough documentation of the entire medical device development process
Follow these four key tips for successfully managing your medical device Design History File.
1. Go Digital
While using paper files initially is fine, it’s best to transfer them to digital storage as soon as possible to ensure that you stay organized and compliant with FDA regulations.
2. Keep It Separate
A clean, clear and concise DHF is crucial if you’re ever audited by the FDA, so it’s best to store the Design History File independently of your project file. This helps to ensure that it doesn’t get merged and muddled in with your project development notes.
3. Stay Current
Start traceability of your design processes right from the outset of the project, and keep them current during the entire process.
4. Get the Whole Team Involved
To ensure your Design History File is thorough and comprehensive, your entire design team should have access. Make sure that everyone who contributes to the project has both read and write access to the file, and remind them to update it regularly.
Ideally, your Design History File contains all the necessary information about your Design Controls. Without this crucial data, you’re at risk of not being in compliance, and you might face consequences from the FDA. Use these four tips for staying current with your DHF so you can succeed at what you love doing most — creating medical devices that improve peoples’ lives.