ISO 14971 Risk Management for Medical Devices

Before delving into ISO 14971 for Medical Device - Application of risk management to medical devices, it is essential to comprehend risk management. ISO 14971 Consulting risk management involves identifying, analysing, controlling, and preventing failures that can result in harmful consequences when using medical devices, unlike business risk management.

Organizations need to prioritize risk management for medical devices since risks linked to device failures can seriously impact both patients undergoing procedures and the organizations.

If your medical device companies intend to distribute medical devices in the United States or Europe. Your organization must have a Consulting risk management system to comply with regulatory requirements set forth by Quality System Regulation (QSR) and Medical Device Regulation (MDR), respectively. ISO 14971 risk management is a global standard that regulatory agencies require medical device companies to implement in their risk management practices during all stages of the product's life cycle.

What is ISO 14791 Certification?

ISO 14971 deals with managing risks and is the global standard created for the medical equipment sector. This standard sets the industry's top practices from design to maintenance and distribution during the entire life cycle. Furthermore, ISO 14971 offers a detailed description of terms and definitions. Ensuring the safety and effectiveness of your products is essential for your organization, and it is crucial to have a risk management system in place

The risk management process for medical devices as stated in ISO 14971 requires thorough evaluation of all stages of the device’s life cycle, not limited to just medical devices. This involves external and internal processes like suppliers, procurement, sales, business development, quality system procedures, and consumers, which must be fundamental aspects of risk management in the medical device sector.

The ISO 14791 standard outlines terms and principles. It offers a risk management structure for medical devices, such as in vitro diagnostic devices, to assist organizations in identifying hazards, estimating risks, analysing risks, and implementing measures to mitigate risks

What Is Risk Management?

The risk management process outlined in ISO 14791 is meant to cover the entire lifespan of the product, from the beginning stages to disposal at the end. The requirements of this risk management system are essential for ISO 13485 - Quality Management Systems.

The risk management process for medical devices as stated in ISO 14971 requires thorough evaluation of all stages of the device's life cycle, not limited to just medical devices. This involves external and internal processes like suppliers, procurement, sales, business development, quality system procedures, and consumers, which must be a fundamental aspect of risk management in the medical device sector.

Need For Risk Management In Medical Devices

Risk management in medical devices is the methodical process of recognizing possible dangers, assessing, and appraising related risks, and enacting steps to decrease or eradicate them. These systems are crucial for ensuring product reliability and reducing the risk of malfunctions that could have adverse effects on users or the environment.

Medical device risk management is essential to guarantee the safety and effectiveness of medical devices from the beginning of their development to the end of their distribution. Risk management is necessary for medical devices because of their complex nature and the potential dangers they can present to patients and users.

Medical devices can vary from basic instruments to advanced equipment, and any malfunction or negative incidence can result in serious outcomes. Some important factors demonstrating the importance of risk reduction in medical devices are outlined below:

• Safety of patients: Trust is essential in medical devices, as it relies on the relationship between creators and users for devices to function properly. Risk Management plays a key role in guaranteeing the safety and efficacy of medical devices for patients.
• Compliance with regulations: Regulators mandate that medical device companies must pinpoint and address risks in order to guarantee the safety and effectiveness of their product. Regulatory bodies like the European Union’s MDR and global agencies manage medical device manufacturers to prove adherence to risk management standards such as ISO 14971. 
• Quality and Reliability of the product: Giving importance to risk assessment at the beginning of device or process development and continually revisiting these factors throughout the development process are crucial practices. By addressing potential risks early in the product development phase, manufacturers can promote the development of products that are both safer and more effective, leading to a notable decrease in recalls and post-market issues.
• Reduction in Costs: Identifying and addressing risks at an early can result in saving money. Dealing with issues early on in the development stage is usually more cost effective than addressing them after the product has been released, as recalls and fixes can be very costly once the product is already in the market.

ISO 14971, the international standard for the application of risk management to medical devices, comprises several key components that provide a comprehensive framework for managing risks associated with medical devices. These components include:

Risk Management Process: ISO 14971 outlines a systematic process for managing risks associated with medical devices. This process typically the following steps:

• Risk Analysis: Identification of hazards associated with the medical devices and assessment of the severity of harm that could result from these hazards. 
• Risk Evaluation: Determination of the overall risk acceptability based on the likelihood and severity of harm as well as the risk controls in place.
• Risk Control: Implementation of measures to mitigate or eliminate identified risks, including design controls, protective measures, warnings, and instructions for use.
• Risk Management Review: Ongoing monitoring and review of the effectiveness of risk controls and the overall risk management process.
• Risk Management File: Manufacturers are required to maintain a risk management file that documents all aspects of the risk management process, including risk assessments, risk control measures, risk management plans, and risk management reports.
• Production and Post-Production Information: ISO 14971 emphasizes the importance of considering risks associated with the production, distribution use, and disposal of medical devices, and requires manufacturers to provide relevant information to users to users to ensure safe and effective device use.
• Risk Management Report: Manufacturers are required to prepare a risk management report that summarizes the results of the risk management process, including the identification of hazards, evaluation of risks, implementation of risk controls, and overall risk assessment.

These components work together to provide a structured approach to risk management for medical devices, helping manufacturers ensure the safety and effectiveness of their products while meeting regulatory requirements and maintaining product quality.

Trust is the foundation of the medical device industry, between the creators and users relying on devices to function properly. Put yourself in the patient shoes about to undergo a medical procedure. The patient likely doesn’t give much consideration to the potential risks of the medical devices that will be utilized.

Typically, the patient has confidence in the skills of the clinicians. The patient rarely questions if the products used by the clinicians are safe and have undergone extensive testing. The patient may not always be aware of it but they assume the risks associated with the medical device that we design, create, and produce. This is precisely the reason why Risk Management holds such significance in the medical device sector.

While risk management may seem complicated, the primary part of the ISO 14971 standard is short with only 14 pages and 9 clauses.

• The extent of something, range, or limits of something.
• Conditions and terms
• Basic criteria for managing risks.
• Analysis of potential dangers
• Assessment of risk
• Managing risk.
• Assessment of overall acceptability of risk
• Report on managing risks

Information regarding the creation and completion of a project.

These are the main supplementary documents that back up those provisions.

• Appendix An Explanation of requirements
• Annex B Summary of the risk management process for medical devices
• Annex C includes questions that can help identify medical device characteristics that may affect safety.
• Annex D discusses the application of risk concepts to medical devices.
• Annex E provides instances of dangers, expected series of occurrences, and risky scenarios.
• Appendix F Risk management strategy
• Annex G Information regarding methods for managing risks
• Annex H Guidance on managing risks for in-vitro diagnostic medical devices 
• Annex I Guidance on the process of analysing risks related to biological hazards is provided 
• Appendix J contains details on safety guidelines and residual risk information.

Every manufacturer of medical devices must establish protocols for managing risks. Procedures that already existed needed to be reviewed and revised post-2019 in order to align with the standard's requirements. Having a process in place is beneficial, but without support from employees and a culture that values risk management, your procedure will not be fully implemented.

Eligibility For Risk Acceptability 

Defining the acceptance criteria at the start of the development process is crucial to ensure the risk analysis process remains as objective as possible. When criteria is set in the plan at the beginning of the design phase, it is less likely to be affected by data gathered during development. Criteria may consist of specific numerical boundaries determined by computing a risk index value. The risk index should be determined based on the likelihood, seriousness, and other factors that help measure the risk of potential damage. The risk acceptability criteria will be utilized before implementing any mitigations or risk controls, making it typically acceptable to have a higher level of risk at this stage.

• Develop a plan for managing risks: Outline planned activities, delegate responsibilities, identify review criteria for risks, set acceptable levels of risk, schedule verification tasks, and plan for production and post-production activities.
• Gather your risk management team: Gather a skilled team familiar with your device's construction, manufacturing processes, field use, and more.
• Utilize risk analysis instruments for risk identification: Select tools for risk measurement (which will be explored further) and apply them for identifying risks introduced by processes, users, suppliers, maintenance tasks, shipping, production equipment, etc.
• Consider the advantages against the drawbacks: It's quite clear, but the ultimate aim is to make sure that the medical advantages of your device are greater than the remaining risks.
• Reduce risks: The aim is to lower risks to an acceptable level. Later, we will discuss risk reduction further and examine how it differs in the 2007 and 2012 editions of ISO 14971.

ISO 14971 Successful Compliance

ISO 14971 presents significant demands and appears to be a major challenge for the quality and regulatory department. Nevertheless, if the procedure is effectively executed, it can decrease the burden of quality and regulations by enhancing the design and safety of devices, leading to fewer nonconformities and incidents in the field.

ISO 13485:2016 mandates taking risk into account across the entire quality management system; once you finish implementing ISO 14971, continue in the same direction. Authorities are consistently emphasizing the importance of continuous risk management efforts, so it is crucial to accept and utilize the procedure to generate positive outcomes rather than viewing it as an obstacle. Prioritize creating a company culture that values risk management. Risk management is a valuable tool to help prioritize growing workloads and ensure overall compliance.

The training and certification on ISO 14971 risk management from CORPSEED provide important skills and knowledge for handling risks related to medical devices. This certification ensures adherence to regulatory standards, improves product quality and safety, supports informed decision-making, and provides a competitive advantage in the industry.