Risk Management
When preparing a medical device for the U.S. market, demonstrating a robust risk management process is critical. The FDA expects manufacturers to apply the principles of ISO 14971 to identify, evaluate, and control risks throughout the product lifecycle—especially in 510(k) and PMA submissions.
At Sobel, we support your team with strategic risk documentation tailored to FDA expectations. We help you build your risk files from scratch or review existing materials, ensuring your approach to safety aligns with regulatory best practices.
How We Support Your Risk Management Process
The FDA doesn’t just want to see that risks were considered—they expect clear, traceable documentation that shows how hazards were identified, mitigated, and monitored. We provide targeted support to help you deliver exactly that.
Here’s how we assist:
Perform critical analysis of your Risk Management Plan and Report
Identify documentation gaps based on FDA risk assessment requirements
Assist with creating or updating Risk Management SOPs, Risk Analysis Forms, Risk Management Report
Provide real-case examples based on your device to illustrate process application
Guide your team on how to apply ISO 14971 in the context of U.S. regulatory submissions
Offer training on risk management activities relevant to FDA compliance, including: Hazard identification and risk evaluation, Risk control planning and residual risk assessment, Benefit-risk evaluation and post-market monitoring
Align your risk management strategy with expectations for 510(k) or PMA submissions
Help demonstrate risk documentation for FDA approval that’s clear, consistent, and audit-ready
Why do you need this service?
We help you prepare risk documentation that satisfies FDA expectations for medical device safety and risk, reducing chances of review delays or rejections.
A systematic approach to risk improves not only compliance, but also the quality and safety of your device—strengthening your market reputation.
Whether your device is cleared via 510(k) or approved through PMA, we check if your risk management files support your case clearly and effectively.
We help you develop and implement a risk management system that not only meets global regulatory requirements but also enhances the safety and reliability of your products.
Remember: Risk management isn’t just part of your submission—it’s part of your product’s identity. With clear documentation and a sound strategy, you reduce regulatory friction and demonstrate a true commitment to safety.
Need Help with Your Risk Management Process?
If you’re uncertain whether your current process is up to par, our team can conduct a thorough review of your documentation (including your Risk Management Plan and Report). We’ll identify any gaps and provide solutions to bring your process in line with the latest standards.
More than that: we offer hands-on support to help your team meet ISO 14971 expectations and navigate FDA risk requirements with clarity. Whether you need a full review or ongoing guidance, we’re ready to help.
Talk to Sobel and make your documentation work for your product and your approval timeline.
