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Risk Management. A Tool or a Curse?

When it comes to implementing and maintaining risk management for medical devices, you likely face the same challenges as many companies. You may even feel overwhelmed. It can be intimidating for people not familiar with the topic, but the reality is that the risk management process is critical. When properly implemented and used, it helps companies design and manufacture safe medical devices, by providing a framework to control and monitor the risks associated with medical devices throughout the product lifecycle.

For medical device manufacturers, you are required to have a risk management process in place. That’s no news, but the issue is that many companies have a compliant system, but not a usable system. When it comes to exercising the risk management process, some team members find the system confusing, feel overwhelmed and the product risk management program becomes a curse.

To break the curse, you must take the right actions and support your team in understanding the process and its benefits. Have a good system, train your team, have a good plan, have your whole QMS interact with your risk management process and things will flow. It is exciting seeing a risk management process working just fine, producing results and eliminating risks before they become problems. It is also rewarding seeing the team excited about risk management.

There are common pitfalls associated with the implementation of a product risk management program. Be mindful of it and avoid them.

First and foremost, have a proper and clear risk management process;

have a proper product risk management plan - you’ll go nowhere without it;

define who owns the risk management file and where it resides;

properly identify characteristics related to safety of the product;

properly identify hazards and hazardous situations associated with a medical device;

define a proper severity of harm scale based on your device risk profile;

define a proper probability of harm scale based on your available data;

define a proper risk acceptability criteria - it could vary by product;

properly perform risk analysis using adequate techniques;

complete and implement proper risk controls measures in their order of priority;

ensure proper controls are carried over to related processes, such as verification and validation activities, as well as supplier controls requirements - not everyone does this;

remember to consider new risks arising from risk control measures;

remember that verification and validation are not risk control measures, but rather evidence of effectiveness;

perform a proper benefit-risk analysis when applicable;

perform a proper risk management review/ report;

remember that relevant information from production and post-production activities shall be collected, reviewed and maintained.

Don't fall into the common pitfall of getting lax between audits – you might end up in the cycle I talked about in my previous article Be Proactive, Not Reactive! Get the right process in place, train and coach your team, but most importantly do the right thing every time. Visit us at to see the ways we can help you implement, exercise and maintain a proper risk management process and program adequate to your company and device type. Make sure your risk management process is your tool, not your curse!

Oscar Garcia - President, QES Medical LLC

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