Benefit-Risk Analysis: Learning from an FDA Case Study

Analysis of the overall benefit-risk for a medical device proves to be very challenging in practice. There is no cookie-cutter formula, and it involves a lot of judgment. Learn about benefit-risk analysis from a FDA case study.


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Medical device risk management is challenging!

I have more than 10 years of experience in building and operating highly effective, and fully compliant risk management systems in the medical device industry.

As discussed in this video, benefit-risk analysis is not easy. However, it is a very important deliverable of your risk management process.

You must be able to persuade regulatory authorities that the probable benefits of your medical device exceed the probable risks associated with its use. 

It is clear that global regulatory authorities are increasingly focusing on risk management. The US FDA is planning to harmonize the Quality System Regulation with ISO 13485, which emphasizes a risk-based approach throughout the Quality Management System. EU-MDR includes many specific requirements for a systematic risk management process. Did you know that EU-MDR references the terms "risk" or "risks" more than 200 times?!

In this new environment, you can expect a high level of scrutiny on your risk management system during a regulatory submission. 

How do you establish an effective risk management process that is not only compliant, but also helps you to accelerate product development and regulatory approval?

I can help you. 

I am an engineer by training. I bring a "problem-solving" mindset to the risk management process. I have a deep understanding of the regulatory requirements. But I also  know how to create a process that is easy to implement and works well across the entire Quality Management System.

If you would like to discuss your specific situation in a confidential setting, click the button below to schedule a free 30-min consultation with me.

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