Generally, when planning, project teams have a broad picture of the goal or process in aim but typically forget the sudden risks found during the development. The planning process should be narrowed down into more specific details about each step of the plan, and as it goes, risk management assessment is applied. This approach leads to risk analysis and a risk management questionnaire to evaluate risks, decide on controls, record findings, and access a prompt response. Nevertheless, risks will still be onboard but manageable to the industry rather than affecting patient care. According to ISO 14971, the risk is a combination of the probability of occurrence of harm and the severity of that harm.   
Indeed, continuous risk assessment management covers all life cycles of the medical device; it needs to be run along with design controls to ensure the benefits and rewards are slowly compounding for project success. After all, risk management of medical devices is intended to assist manufacturers in identifying potential risks, controlling risks, and monitoring the effectiveness of controls.

A structured, continuous approach to risk assessment, as outlined in ISO 14971, is key to preventing overlooked hazards. Narrowing the planning process into specific steps allows teams to focus on each task and identify potential pitfalls early, rather than waiting for surprises. This detailed perspective aids in gathering the right data, deciding on proper controls, and preparing contingency responses—ultimately reducing both the likelihood and severity of harm to patients.

By integrating risk assessment with design controls from the outset, manufacturers can manage and refine their strategies at every stage of the medical device’s life cycle. While it’s inevitable that some risks remain, a well-implemented risk management system helps ensure that these risks are kept within acceptable limits. Continuous monitoring and evaluation mean issues can be identified quickly, corrective actions taken, and benefits gradually realized over time. In this way, risk management not only protects patients but also supports the overall success and sustainability of the project.

One thing to consider with medical devices is that they don't all carry the same level of risks, hence the classification. Implementing different risk-adaptive techniques for different classifications can speed up the process for Class I medical devices, as they pose less risk compared to Class II or Class III devices. Another thing that can help speed up the process is determining which risks must be addressed before the late stages, and which risks can be easily addressed during the late stages of the project lifespan. This allows flexibility for low risks if they appear during the project lifespan as circumstances may change by then. This allows for a more hybrid approach and requires less slow-down on the project progress. 

We can determine the risks which are worth taking by evaluating the residual risk evaluation. Ask yourself on a high level whether the product’s overall residual risk should be considered acceptable. This is really a question of whether your product is better or worse or on par with every other product in the field.

1. Ensure that you compile and communicate the residual risks of your medical device. 
2. One way to understand overall residual risk acceptability is to compare two products 
3. You could compare the risks associated with your product with competitors, have application specialists or experts review your product, or use expert judgment

We should prioritize risk management in balance with speed of development. The product should not have ample risk with it that it harms humans, and also not delayed consuming resources and manpower.

Companies with robust risk management processes know how to stop, pivot and quickly change direction without losing focus of their strategic initiatives.

The risk management process should cover the whole life cycle of the device, from initial conception to decommissioning. This means that you should include risks arising from things such as: 

• poor design, 
• failure in production processes, 
• rough handling during shipping, 
• software bugs, 
• misuse by a user, 
• side effects from using the medical device, 
• component failures, and 
• risks arising during scrapping.  
  

The risk management process must not only be documented, but management should ensure it is effective. Therefore, it is the management’s responsibility to review the suitability of the risk management process at planned intervals to guarantee the effectiveness of it. This requirement should not be confused with risk management review, which is a different activity.  There are also other risk management tools, Fault Tree Analysis (FTA), Risk Matrix and Risk Priority Number.

We should prioritize early stage risk assessment. A risk management file needs to be created and maintained. Important parts of the risk management file are the risk management plan and the risk management report, which is created after the review of the execution of the plan.

Effective risk management in medical device development requires balancing safety, efficiency, and cost. While minimizing risk is essential (especially under ISO 14971 guidelines), overly cautious approaches can delay innovation and inflate costs. It is important to prioritize early-stage risk assessments to help identify and mitigate major hazards upfront, reducing the likelihood of costly redesigns later. However, not all risks warrant immediate action; some can be monitored and addressed as development progresses. The key is to evaluate risks based on severity, probability, and detectability, ensuring that critical failures are prevented while allowing manageable risks to support timely product development.