Lessons from a Class I Recall - A Case Study
Watch how failing to recognize a new hazard or hazardous situation arising from a risk control measure can lead to a Class I recall and learn about a few best practices to avoid this situation.
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 well-intentioned risk control measures intended to enhance safety can also inadvertently lead to additional hazards that should also be addressed during design and development.
It can lead to a Class I recall!
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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