Risk Management File Remediation

Is your risk management file current?

From product development through commercialization and beyond, developing and maintaining a comprehensive risk management file helps make better products and ensures compliance with regulations. However, companies tend to find themselves getting behind keeping those files up to date. AlvaMed’s team of experienced product development engineers can help you identify gaps and bring your risk management file into compliance with the current version of ISO 14971.

We will review your current risk management file to identify gaps based upon current ISO 14971 and regulatory requirements.

We will help you develop a plan to update the necessary documents. We can provide compliant templates for common risk management tools if necessary.

We will work directly with your team to update each of the documents within your risk management file. Our support can range from reviewing your prepared drafts to hands-on updating of your files.

We can help you establish and maintain processes for periodic review and updating of the risk management file to ensure it always remains current.

AlvaMed’s team of engineers know how to do product risk management the right way, ensuring it becomes a useful tool in your product development process.

Our clients are happy to be references – we are happy to share their contact information when you meet with us.

Ready To Schedule A Call?

We look forward to discussing AlvaMed’s services with you.

Risk Management File Remediation FAQ's

ISO 14971:2019 is recognized by both the US FDA and EU Notified Bodies as the gold standard for performing medical device product risk management. All regulatory submissions are expected to comply with this standard.

It is potentially out of date if it was built following an older version of ISO 14971 and has not been updated since. Even newer files built following the current standard may be out of date if companies lack a formal process for periodic review.

AlvaMed’s experts have worked with many different product types and have seen many ways to comply with risk management requirements. This allows us to offer best practice guidance while ensuring requirements are being met.

Jon Saltonstall

Vice President of Regulatory and Quality Compliance

Jon and his team of medical device engineers understand that preparing a good risk management file helps lead to improved product designs and fewer questions during regulatory submissions.

Are you ready to get your risk management files current with the latest standards and best practices?

Schedule time to meet with Jon Saltonstall. Let AlvaMed help you get your risk management files up to date before it’s too late.