What is Risk Management in Medical Device Development?

What is Risk Management in Medical Device Development?


Risk management is an essential part of medical device development and regulation. It helps manufacturers identify and mitigate potential hazards, ensuring that their products are safe, effective, and reliable. By complying with regulatory requirements and implementing effective risk management processes, manufacturers can minimize the risks associated with medical devices and promote patient safety.



Risk management involves identifying potential hazards and mitigating the risks associated with them. It is a systematic approach that involves assessing risks and implementing controls to minimize their impact on patients, healthcare providers, and other stakeholders.



The goal of risk management is to ensure that medical devices are safe, effective, and reliable, and that their benefits outweigh their risks. By managing risks throughout the development process, manufacturers can reduce the likelihood of adverse events, product recalls, and other negative outcomes.



Regulatory Requirements for Risk Management in Medical Device Development

Medical device manufacturers must comply with strict regulatory requirements for risk management. In the United States, the Food and Drug Administration (FDA) requires manufacturers to conduct risk assessments and develop risk management plans as part of the pre-market submission process. This involves identifying and assessing potential hazards, estimating the likelihood of harm, and implementing controls to mitigate risks.



Similarly, the European Union’s Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR) require manufacturers to perform risk assessments and develop risk management plans as part of the CE marking process. The risk management plan must include a description of the risk management process, risk assessment results, and a list of risk control measures.



The Role of Risk Management in Post-Market Surveillance

Risk management is not limited to the pre-market phase of medical device development. It also plays a critical role in post-market surveillance, where manufacturers must monitor the safety and performance of their products and take appropriate action to address any issues that arise.



Post-market surveillance involves collecting and analyzing data on adverse events, complaints, and other safety-related information. This data can help manufacturers identify trends and potential safety issues, assess the effectiveness of risk control measures, and make informed decisions about product design and labeling.

ISO 14971

ISO 14971:2019 is a (complementary) standard that provides guidance for managing risk in the design and manufacture of medical devices, which is a key aspect of a medical device manufacturer’s quality management system as required by ISO 13485.

Risk management process – Example
  1. Define the scope and purpose of the risk management process: Identify the medical device, intended use, and identify the potential hazards associated with the device.

  2. Hazard identification: Conduct a thorough risk analysis to identify all potential hazards associated with the device. This includes both known and foreseeable hazards.

  3. Risk assessment: Evaluate the likelihood and severity of harm associated with each identified hazard. This involves considering the probability of occurrence of the hazard and the potential severity of the harm caused.

  4. Risk control: Develop and implement risk control measures to reduce or eliminate the identified hazards. This may involve design changes, warnings, instructions for use, or additional safety features.

  5. Risk evaluation: Evaluate the effectiveness of the risk control measures and assess whether residual risks are acceptable.

  6. Risk communication: Communicate the results of the risk management process to stakeholders such as regulatory bodies, patients, and healthcare providers.

  7. Risk review: Continuously review and monitor the device and its associated risks throughout its lifecycle to identify any new hazards or risks and to ensure ongoing compliance with regulatory requirements.


This process is iterative and may involve revisiting previous steps as new information becomes available. It is essential to document each step of the risk management process and keep accurate records for future reference.

This article serves as information only and does not represent an official or agreed position of CENIT Consulting. The opinions expressed in the article are solely those of the authors. Although every effort has been made to ensure the accuracy of the content, CENIT Consulting cannot be held responsible for any loss or damage that may result from relying on the information provided, except where such liability cannot be excluded by law.