IEC 62366 Consulting
IEC 62366 Consulting is a specialized service that helps medical device and combination product manufacturers comply with the international standard for usability engineering, IEC62366. The standard establishes guidelines for the design and testing of medical devices to ensure they are safe and easy to use for both healthcare professionals and patients. IEC62366 consulting is intended for medical device manufacturers, engineers, and usability experts who are involved in the design, development, and testing of medical devices.
What is IEC 62366-1?
IEC 62366-1 is a standard that specifies the requirements for the usability engineering process for medical devices. It is part of the larger IEC 62366 standard for usability engineering and is specifically focused on the process of designing and testing medical devices to ensure they are safe and easy to use for both healthcare professionals and patients. The standard covers a wide range of topics including user-centered design, human factors engineering, usability testing, and risk management.
User-centered design: This approach focuses on understanding the needs, goals, and tasks of the end-users of the medical device in order to design a product that is intuitive and easy to use. It involves conducting user research, testing, and evaluation throughout the development process.
Human factors engineering: This is the process of designing and testing medical devices to ensure they are safe and easy to use for both healthcare professionals and patients. It involves taking into account factors such as human anatomy, physiology, and cognitive psychology to design medical devices that are appropriate for the intended users and use environment.
Usability testing: This is the process of evaluating the usability of a medical device by testing it with representative users. It involves observing and collecting data on how users interact with the device and using that data to identify and address any usability issues.
Risk management: This process involves identifying and assessing risks associated with the use of medical devices, and implementing measures to minimize or mitigate those risks. It is an integral part of the usability engineering process and helps ensure that medical devices are safe and effective for their intended use.
It provides guidance on how to identify and address potential usability issues throughout the product development process. The standard is intended to be used by medical device manufacturers, engineers, and usability experts who are involved in the design, development, and testing of medical devices. Compliance with IEC 62366-1 is a regulatory requirement for many medical devices in order to be marketed in many countries.
What is IEC 62366-2?
IEC 62366-2 is a standard that provides guidance on how to conduct usability testing of medical devices. It is part of the larger IEC 62366 standard for usability engineering and is intended to be used in conjunction with IEC 62366-1. The standard provides guidelines on 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 standard also includes information on how to use the results of usability testing to identify and address usability issues. Compliance with IEC 62366-2 is a regulatory requirement for many medical devices in order to be marketed in many countries.
What Is the Difference Between IEC 62366-1 & IEC 62366-2?
IEC 62366-1 focuses on the overall process for usability engineering, which includes user-centered design, human factors engineering, usability testing, and risk management. IEC 62366-2 provides more detailed guidance on how to conduct usability testing specifically. While IEC 62366-1 provides the overarching process for usability engineering, IEC 62366-2 gives more specifics on how to properly conduct usability testing and report on the results obtained.
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 team of experts can assist in all stages of the usability engineering process, from user research to risk management. We provide a comprehensive solution that includes user-centered design, human factors engineering, usability testing, and risk management, to facilitate the development of a medical device that is safe and easy to use for both healthcare professionals and patients.
Step 1: Defines use specifications: Improvita’s team can help medical device manufacturers define the intended use and user characteristics for a medical device by conducting user research and testing. This information can be used to create use specifications that are tailored to the needs of the intended users.
Step 2: Defines user interface characteristics related to safety: Improvita defines user interface characteristics that are related to safety by conducting user research and testing. We can also provide guidance on how to design a user interface that is easy to use and minimizes the risk of user error.
Step 3: Identify foreseeable hazards: Improvita’s team can identify potential hazards associated with the use of a medical device by conducting user research and testing. They can also provide guidance on how to design a medical device that minimizes the risk of these hazards.
Step 4: User interface specifications: Improvita can help create user interface specifications that are tailored to the needs of the intended users.
Step 5: User interface evaluation plan: Improvita can help medical device manufacturers develop a plan for evaluating the usability of a medical device’s user interface.
Step 6: Formative evaluation: Improvita can conduct formative evaluations, which are used to assess and improve the usability of a medical device during the development process.
Step 7: Summative evaluation: We’ll conduct summative evaluations, which are used to assess the overall usability of a medical device. This includes testing the device with representative users and using the results to identify and address any usability issues.
Why choose our IEC62366 consulting service?
Improvita’s team of experts can help in all stages of the usability engineering process to help develop a medical device that is safe and easy to use for both healthcare professionals and patients. We can assist with user-centered design, human factors engineering, usability testing, and risk management, all aimed at developing a medical device that is compliant with international standards and meets the needs of healthcare professionals and patients. Choosing Improvita gives you the confidence that your product is in good hands with a team dedicated to developing a product, that is compliant with international standards. If you want to know more about Improvita’s IEC62366 consulting service and how it can benefit your product, don’t hesitate to contact us!
