The Design History File is a record of all the required design controls and how they were defined and implemented as your med tech product development progressed.
But it’s all too easy to misfile or lose the issues and drafts of all the documents you’ll generate during a long and complex development process.
And those omissions can increase the risk of an incomplete DHF and a failed regulatory audit.
When you download one of our eBooks or guides, we may occasionally send you further blog or content offers that we believe you may also find interesting or helpful. We hope that's a reasonable expectation on our behalf and you can choose to opt out or change your preferences at any time.