Lessons from an FDA Warning Letter - A Case Study

Watch how failing to update the risk matrix based on post-market surveillance data led to an FDA warning letter and a few best practices for you to avoid this situation.


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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.

The case study above highlights how FDA is focusing on deficiencies in the risk management process. 

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 an audit or inspection.

How do you establish a fully compliant risk management system without creating an excessive burdensome process?

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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Book a free 30-minute consultation with Dr. Naveen Agarwal today!


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