Project Description

  • risk management and usability

Risk Management and Usability: Ensuring Safety and Efficacy in Medical Devices

Risk management and usability are essential processes for the safety and effectiveness of medical devices. They aim to identify, assess, and mitigate risks associated with product use while ensuring the product is easy and safe to use.

Importance of Risk Management and Usability

Risk management and usability are crucial for patient, user, and healthcare professional safety. They can help prevent accidents, injuries, and product damage. Additionally, risk management and usability can improve product efficiency and productivity.

What Is Done in Risk Management and Usability

Risk management and usability involve a series of activities, including periodic risk reviews, implementing control measures, assessing the effectiveness of these measures, post-market monitoring, and communicating changes to users and healthcare professionals. In summary:

  • Risk Identification: Potential hazards related to product use are identified and thoroughly evaluated.
  • Risk Assessment: Considering the probability and severity of risks, they are assessed and measured.
  • Risk Mitigation: Control measures are applied to reduce identified risks.
  • Assessment of effectiveness: risks are measured again after control measures.
  • Post-market monitoring: throughout the product life cycle, risk management, which is a “living” document, remains evaluated and fed.
  • Product Evaluation: clarity in communication and interface between product and user.


ANVISA, CE MDR, and other regulatory agencies require risk management and usability for medical products. Regulations specify requirements for risk identification, assessment, and mitigation. Risk management and usability have various standards and guidelines, including:

  • ISO 14971: Risk Management for Health Products.
  • IEC 62366-1: Applicability of Human Factors Engineering to Devices Devices – Part 1: General Requirements for Safety Related to Usability.
  • IEC 60601-1-6: Medical Electrical Equipment – General Requirements for Basic Safety and Essential Performance — Collateral Standard: Usability.
  • Applying Human Factors and Usability Engineering to Medical Devices.

Examples of Risks

Some examples of risks that can be identified and mitigated through risk management and usability include:

  • Usage Errors: The product may be used incorrectly, causing injuries or damage.
  • Predictable and Unpredictable Misuse: The product may be intentionally or unintentionally operated incorrectly.
  • Allergic Reactions: The product may cause allergic reactions in some users.
  • Manufacturing Defects: The product may have manufacturing defects, leading to failures or injuries.

How Passarini Group Can Assist Your Company

Passarini Group offers support services in building risk management and usability for companies in the healthcare sector. We have a team of experts with extensive experience in the field who can help companies implement these processes effectively. Passarini Group services include:

  • Assistance in implementing a risk and usability management process.
  • Team training.
  • Technical support.


Risk management and usability are essential tools to ensure the safety and efficacy of medical products. Passarini Group can help companies implement effective risk management and usability processes that will protect patients, users, and healthcare professionals.

Contact Passarini Group today to know more about our risk management and usability services, click here.


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