Medical Device Risk Management

Safety risk management for your medical device is not a nice-to-have; it’s a global regulatory requirement and an integral part of the medical device product development lifecycle. Medical device risk management is intended to ensure a device is reliable, works as expected and causes no harm. It is also one of the more complex aspects of regulatory compliance.

 ISO 14971 is the global standard for medical device risk management, recognized by authorities across the US, Europe, Canada, Australia and more. Designed to help medical device manufacturers meet critical regulatory risk management requirements, ISO 14971 specifies and regulates the risk management process medical device manufacturers should follow to avoid the possible hazards associated with the device throughout all stages of the lifecycle—from design to post-market.

 While striking the right balance between a rigorous and effective risk management strategy and adhering to budgets and timelines can prove daunting, cutting corners in your risk management process can cause dire consequences. The best way to keep costs down, adhere to regulatory requirements and get your product to market faster is to incorporate risk management procedures and practices across the entire medical device product development lifecycle.

 But what exactly does that entail? Here’s an overview of what the medical device risk management process should look like.

Five Stages of Medical Device Risk Management:

1. Planning: Start by creating a risk management plan for your medical device that defines the risk management process you intend to follow and roles and responsibilities. This product-level document should include a deep dive into every possible risk associated with your product and include a risk analysis, risk evaluation, risk controls and how you plan to monitor the risks going forward.  
2. Risk analysis: Begin your medical device risk assessment by identifying all the potential ways a device could fail or how a user might inadvertently misuse it. You might even look at similar devices on the market to see where they went wrong. 
3. Risk evaluation: Based on your list of potential hazards, evaluate and estimate the probability of hazardous situations occurring, how likely they are to cause harm and the severity of the harm imposed.
4. Risk control: With a clear understanding of the risk profile of your device, define the controls you plan to apply to mitigate or reduce the occurrence and intensity of those risks to an acceptable level.
5. Monitor the risks ongoing: Define how your post-production information will be captured and used to monitor the effectiveness of those controls going forward. 

When it comes to regulated product development, be sure to incorporate risk management activities across the entire product lifecycle. Waiting too late in the process to consider risk management will end up costing you time and money and may lead to redesigns, redevelopment, and retesting.

Fortunately, there are tools and resources out there that can help you manage your risk management processes and deliver a safe and effective product to market quickly and cost-effectively. At Sterling, we’ll help you bridge the gap between fast-paced product development, complex medical device risk management requirements and proof of compliance using Polarion. The browser-based regulatory-compliant software program lets you link standards to specific procedures or product requirements to ensure you satisfy all regulations. Plus, Polarion will run trace reports to ensure testing has been completed or identify those requirements that haven’t been tested—all in a matter of seconds.

For more information about how to implement a robust medical device risk management program, contact us here.