Risk Management Simplified: Streamline Your FDA Submission with a Hazard Analysis Worksheet

As you’re preparing your medical device for market, one of the regulatory checkpoints you must pass is proving to the FDA that you mitigated any risks associated with your product to the best of your ability. The only way to show you’ve done just that is to meticulously document hazards — potential sources of harm.

The challenge? There are countless potential sources of harm.

Acoustic energy hazards, biological agent hazards, data hazards — the list goes on. And you need to check to see if each one is applicable to your product.

To avoid gaps in your documentation, download our hazard analysis worksheet. It lays out every potential hazard from the corresponding ISO standard. You can fill in the spreadsheet with the rest of the information needed to feel confident about your FDA submission.