ISO 14971: Risk Management for Medical Devices

What is risk management?

Risk management in the medical device industry entails identifying, assessing, and mitigating potential hazards and risks associated with medical devices throughout their lifecycle. According to ISO 14971, it involves the systematic application of management policies and practices to analyze, evaluate, control, and monitor risk. Risk management essentially aims to continuously and systematically reduce risk to produce safer products. While it’s not possible to eliminate risk entirely, the goal is to avoid unacceptable risk.

Why is risk management important for medical devices?

• Regulatory requirements
  ISO 14971 is the enforced or expected standard for Risk Management. The regulatory requirement is described in EU-MDR (article 20 §9: Risk management must be an integral part of the quality management system) and FDA 21 CFR 820.
• Avoidance of product recalls
  Effective risk management helps prevent noncompliance and safety violations that can lead to costly and reputation-damaging medical device recalls, lawsuits, fines, and lost future sales.
• Cost
  Identifying and understanding potential risks helps to minimize the cost of corrective measures and ensures cost-effective medical device development.
• Ethical responsibility
  Risk management practices demonstrate a moral and ethical commitment to delivering safe medical devices to patients who rely on their products to lead full lives.
• Improved communication
  A teamwork approach can make risk management a collaborative effort for all stakeholders in medical device development.

What are the main challenges in medical device risk management?

The journey to getting regulatory clearance can be a long and laborious process. However, we know that adequate risk management saves lives, and it can help safeguard the profitability of development companies, which further adds to its significance.

One of the main challenges is the lack of proper tooling for collaboration. Organizations are still using 15+ column Excel sheets with hundreds of risk entries. This results in no versioning or traceability. This can make it difficult to create and define the risk matrix, and/or have difficulty tying risk mitigation to design controls.

When each business unit has its own standard operating procedure (SOP) another common challenge in medical device risk management can occur, which is organizational misalignment. In this case, every process has a different owner, and there isn’t a standardized interpretation of the Divisional Standard. There are different terms and applications. The use of different tools leads to siloed information access. Organizational misalignment also leads to update cycles being out of sync.

What is ISO 14971?

ISO 14971:2019 is the international standard for risk management in medical devices. ISO 14971:2019 has been recognized as the consensus standard by the FDA and has also been harmonized with the EU MDR.

ISO 14971:2019 details a comprehensive framework for managing the risks that are associated with medical devices. This standard specifies requirements for manufacturers to identify the hazards associated with any medical device they are developing, to analyze these risks, to plan and carry out their reduction/mitigation, and to monitor the effectiveness of these controls (mitigation efforts). Every single one of these aspects must be meticulously documented to provide evidence of an adequate risk control process.

The benefits of ISO 14971

Works with the other ISO standards

ISO 14971 works in tandem with other ISO standards as a risk management framework for medical device safety and efficacy. The integration of ISO 14971 with medical device-specific ISO standards enables medical device manufacturers to minimize risks to acceptable levels. IEC 81001-5-1 is a standard focused on cybersecurity risk management related to medical devices and software, although it has not yet been harmonized with other widely accepted standards. As a process norm in Software as a Medical Device (SaMD) development, IEC 62304 recommends using ISO 14971 to help ensure that medical software products meet high safety standards throughout their development and operational phases.

Prepares medical device companies for the future

The risk awareness standards of ISO 14971 give medical device manufacturers the foresight needed to meet evolving regulatory demands, simplifying their compliance processes in an ever-changing landscape. By systematically identifying and managing potential hazards, medical device makers can anticipate and adapt to technological advancements for a competitive edge.

Is an industry-specific framework

ISO 14971 offers a specialized framework tailored to the medical device industry by focusing specifically on the unique requirements for medical devices to precisely address industry-specific risks and challenges. These guidelines streamline and lay out risk management for medical device manufacturers to ensure compliance and smooth global market access.

Ensures compliance with EU regulations

The EU's Medical Device Regulation (MDR) mandates that medical device manufacturers meet stringent European requirements for clinical evaluation, postmarket surveillance, and transparency in risk management in accordance with ISO 14971 for market access across Europe.

E-book: EU MDR and what it means for MedTech product developers

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Key regulations and standards for ISO 14971 risk management

• ISO 13485: While ISO 13485, the international standard for quality management systems specifically designed for medical device manufacturers, incorporates some risk management requirements, they are limited and do not mandate the comprehensive device lifecycle approach defined by ISO 14971.
• ISO 10993: When considering the biological safety of medical devices, ISO 10993, a standard for the biological evaluation of medical devices, factors into the risk management process provided for in ISO 14971.
• ISO 60601 specifies the basic safety and essential performance requirements for medical electrical equipment. Risk management principles from ISO 14971 were incorporated into the third edition of ISO 60601 for their relevance in meeting regulatory requirements for medical devices.
• ISO 62366 specifies usability requirements for medical device development and complements the ISO 14971 risk management process by focusing on usability engineering in the design and development of user interfaces. It emphasizes the identification and mitigation of use errors and associated risks, which closely relates to the systematic approach of ISO 14971.
• ISO 81001-5-1: While ISO 14971 is the internationally recognized standard for risk management focused primarily on the safety of medical devices throughout their lifecycle, IEC 81001-5-1 extends this risk management approach specifically into the domain of cybersecurity for health software and health IT systems. IEC 81001-5-1 builds on the principles of ISO 14971 by adapting its safety-focused risk management framework to address security risks associated with software, including threats from unauthorized access, tampering, and cyberattacks.

Main benefits of using Codebeamer for Medical Device Risk Management

Standardization is key to avoiding problems that could occur during an audit. Using PTC’s Codebeamer technology can help you prepare for them. With Codebeamer you can plan and schedule audits and build comprehensive, and actionable audit checklists. Using our pre-configured templates can help you hit the ground running in the delivery of regulated products. The capabilities of Codebeamer’s Medical Audit & CAPA Template support adherence to regulatory requirements, such as ISO 14971:2019, and simplify audit preparations. You can customize our templates to suit your organization’s individual needs.

Only using one tool for the whole development process allows you to be more effective in training new people on the process. With Codebeamer you can eliminate human error, due to having a fully automated process, while also documenting every step of the process and running tests to see if it’s being implemented or not.

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How does Codebeamer help with medical device risk management and assessment?

In Codebeamer you can easily build a library of hazards. Situations will provide additional inputs based on probability. For proper assessments, these inputs need to be taken into consideration. Once risks have been assessed, you can define mitigation requirements. Codebeamer and the Medical Audit & CAPA Template provide great support for this process as well. Once your risks have been evaluated, and your root causes have been analyzed you can link the risk items to all the hazards. Once this has been done control measures show you what new requirements need to be created. After you implement these new requirements Codebeamer will show you if they are acceptable or need to be revisited. This whole process can happen in sync with your release schedule.

E-book: Introduction to ISO 14971:2019 for MedTech

Ensure the safety and success of MedTech innovations with essential tools for effective risk management.

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