Risk Management – How to document a Risk Management Plan (RMP)?

The development of new medical devices or any new project brings a new set of risks. A risk management plan (RMP) must be developed at the start of the risk management process for a new project or device development, according to ISO 14971. However, risks cannot be avoided entirely; they can only be mitigated and anticipated through an established risk management plan. It is recommended that the following components be included when documenting the RMP to ensure that the development and product teams are aligned with the risk management plan and are responsive and agile when dealing with risk impacts.


Define the purpose of identifying the risk

The scope of the medical device RMP is to identify risks by anticipating potential product development and manufacturing activities from design to market release. To market a device, the organization should review and update the RMP to ensure that the device was manufactured with appropriate measures and is compliant with industry standards for collecting post-market feedback to ensure the device’s performance as defined for the intended use.

Furthermore, the team can easily leverage and create an RMP in the early stages of the device development process and include updates as and when enhancements and implementations occur in subsequent phases.


Overview of the device development process to analyze the risk

Describe the device design, functions, intended use, environmental conditions required, end-user and indications while documenting the RMP. Along with this, refine the RMP by excluding common issues from the risk analysis coverage. This section will assist the team when a potential risk is identified from the risk plan; The analysis process begins with documenting the changes, their ramifications, and assessing the consequences and their likelihood to determine the mitigation steps. The risk analysis considers the organization’s financial loss, brand reputation, resources, time, and the severity of the risk impact on end-users.


Prioritize and develop a risk strategy

Determine the risk’s priority based on the sources of occurrences, likelihood, and potential impact. Create a comprehensive risk management strategy to ensure that the medical device is safe for its intended use as specified in compliance regulations. This phase entails estimating the current scope of the product and identifying risk impact on priority resolutions. As a result, the product development and manufacturing processes were not slowed or disrupted in preparation for market release.


Evaluate the risk management activities

After identifying and analyzing the risk impact:

  1. Create a step-by-step list of risk management activities.
  2. Implement techniques such as Fault Tree Analysis, Benefit-risk Analysis, and others, including the activities of each phase of the treatment plan.
  3. Create a strategy for dealing with high-priority risks quickly and effectively without jeopardizing the device/product development timeline.

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