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IEC 62366 Consulting

The International Electrotechnical Commission (IEC) is a worldwide organization for standardization across all national electrotechnical committees. Some regulatory authorities (e.g., Food and Drug Administration, European Union, etc.) have recognized or harmonized to IEC 62366 for Usability Engineering; and therefore, require conformance. IEC 62366 Consulting is a specialized service that helps medical device and combination product manufacturers comply with the international standard. The standard specifies a process for the design and evaluation of medical device usability as it relates to safety. IEC 62366 consulting is intended for medical device manufacturers, engineers, and usability experts who are involved in the design, development, and testing of medical devices.

Learn more about the IEC 62366 standard and how Improvita can help you stay compliant with the standard.

What is IEC 62366?

IEC 62366 is the international collateral standard for Usability Engineering applied to medical devices. It consists of two parts: IEC 62366-1 and IEC 62366-2. IEC 62366-1 specifies the Usability Engineering process requirements that need to be applied during medical device development. It is focused on the process of designing and testing medical devices to demonstrate they can be used safely and effectively by the intended users (e.g., healthcare professionals (HCPs), patients, caregivers etc.). The standard covers topics that include preparing a use specification, defining hazard-related use scenarios, planning user interface evaluations, and conducting Summative Usability Testing. IEC 62366-2 is a technical report that provides guidance on how to conduct the usability evaluations to satisfy the requirements, and includes helpful details regarding how to plan, conduct, and report on usability testing, including the selection of participants, the design of test scenarios, and the collection, and analysis of data. The technical report also includes information on how to use the usability testing results to identify and address usability issues.

How can Improvita help with the Usability Engineering Process as per IEC 62366?

Improvita specializes in helping medical device manufacturers comply with the international standard for Usability Engineering, IEC 62366. Our expert team can assist in all stages of the Usability Engineering process, from early user research, which identifies the User’s needs, through Summative Validation study development, execution and reporting. We provide a comprehensive solution that includes user-centered design, Human Factors Engineering, and risk management, to facilitate the development of a medical device that is safe and efficacious in the Users hands (e.g., HCPs, patients, caregivers, etc.).

User-centered design:

This approach focuses on understanding the needs, goals, and tasks to be performed by medical device Users. The goal is to design a product that meets a true unmet need and is intuitive and easy to use. It involves conducting user research, testing, and evaluation throughout the development process.

Human Factors Engineering:

Within the medical device and combination product industries, Human Factors Engineering is the process of designing and testing devices and/or products to ensure they are usable for the intended user (e.g., healthcare professionals, patients, and caregivers etc.). It involves the observation and assessment of the user-device interaction from a perception, cognition, and manual action perspective to identify potential areas of risk (or use related errors) that could render the product less safe or efficacious in the User’s hands. The Human Factors Engineering process supports the design of medical devices that are appropriate for the intended users and use environment.

Risk management:

This process involves collaboratively identifying and assessing risks associated with the use of medical devices and implementing measures to minimize or mitigate those risks. It helps support the development of products that are safe and effective for their intended use.

Our integrated process provides an elegant approach for User Centered Design, Human Factors Engineering compliance to IEC 62366, and risk management/risk mitigation. At a high level, our process includes the following steps:


Step 1: Define the context of use.

Improvita’s team can help clients define use specifications, including intended use, users, use environments and user characteristics for a medical device by conducting usability research. This information can be used to develop use specifications that are well matched to the needs of the intended users.


Step 2: Define the user interface characteristics related to safety.

Our team will define user interface characteristics that are related to safety and usability. We can also provide guidance on how to design a user interface that is easy to use and minimizes the risk of use error.


Step 3: Identify known or foreseeable hazards, hazardous situations, and hazard-related use scenarios.

Our team will identify potential hazards associated with the use of a medical device and make recommendations for de-risking the medical device (e.g., minimizing the risk of potential hazards).


Step 4: Plan for user interface evaluation.

Improvita can help medical device manufacturers develop a plan for evaluating the usability of a medical device’s user interface. The three main goals here are to assess accessibility, functionality, and the user’s direct experience with the medical device. Assessing these key points helps to identify any specific risks or hazard-related use scenarios that would go along with the operation of a medical device. This can aid in the planning for user interface evaluation and therefore prepare for a Formative Evaluation (outlined below in step 5).


Step 5: Conduct appropriately scaled Formative Evaluations.

Our team conducts Formative Evaluations, which are used to assess and improve the usability of a product during the development process.


Step 6: Conduct Human Factors Validation/Summative Testing.

We handle all aspects to complete Summative Evaluations, which are used to assess the overall usability of a medical device. This includes testing the device with representative study participants and using the results to validate that the product can be used safely and effectively.

Why choose Improvita for IEC 62366 Consulting?

Improvita’s team of experts can help in all stages of the Usability Engineering Process. We support product development by leveraging our expertise in user-centered design, Usability Engineering, usability testing, risk management, and regulatory compliance with international standards. Our experts provide valuable insights into how to strategically position your device for success.

To learn more about Improvita’s international compliance and user focused design services and/or how we can help bring your medical device to market, contact us to discuss your specific needs.