Full-cycle Medical Device Research Center
Research Support Services
- · Fabrication technology support using laser processing and general-purpose machine tools
- · Medical device prototype fabrication support using 3D modeling and 3D printing
- · Support for commercialization-stage product fabrication via injection molds
Technical Support for Realizing Ideas
- · Software development support for device control and function implementation (embedded systems)
- · Electronic circuit design and PCB fabrication support
Equipment in the Prototype Fabrication Support Lab
Contact
Phone
02-2072-4624
Usability Evaluation
Usability refers to the characteristic of establishing "the effectiveness, efficiency, and satisfaction with which specified users achieve specified goals in a specified environment." It is a measure of how easy a device is to use and how conveniently it can be operated.
What Is Medical Device Usability Evaluation?
- · Medical device usability evaluation is an evaluation that verifies the accurate and safe use of a device by its users within the use environment, in order to identify and mitigate use errors and use-related risks.
(Source: Korea Health Industry Development Institute (KHIDI), Understanding Medical Device Usability Standards and Analysis of Domestic Response Strategies, 2015) - · Medical device usability evaluation is described in the collateral standard of IEC 60601-1, which requires the basic safety and essential performance of electrical medical devices, and in IEC 62366-1, which requires usability engineering processes for all medical devices.
- · Medical device usability evaluation assesses safety and convenience rather than efficacy. Users of the device—medical staff such as physicians, nurses, and radiologic technologists who actually use medical devices in clinical settings, or patients—participate directly in the evaluation, handling and assessing the device. In other words, medical device usability evaluation identifies and preemptively prevents potential safety-related factors that may arise when users operate the device directly.
Devices Subject to Evaluation
Usability evaluation applies to all medical devices. Furthermore, in accordance with ISO 13485:2016—the standard for medical device manufacturing and quality management—usability is a mandatory requirement of GMP.
Our evaluation lab conducts usability evaluations for all medical devices—even those that do not use electricity—that may pose hazards or that aim to add value and enhance user convenience.
Reference International Standards
Our institution complies with and refers to the following standards for usability evaluation.
| Standard No. | Standard Title |
|---|---|
| ISO 13485:2016 | Medical Devices - Quality Management Systems - Requirements for regulatory Purposes Medical device quality management systems |
| IEC 60601-1-6:2010/AMD2:2020 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability Collateral standard for basic safety and essential performance of electrical medical equipment: Usability |
| IEC 62366-1:2015/AMD1:2020 | Medical Devices-part1: Application of usability engineering to Medical devices Application of usability engineering to medical devices |
| IEC TR 62366-2:2016 | Medical Devices-part2: Guidance on the application of usability engineering to Medical devices Guidance on the application of usability engineering to medical devices |
| ANSI/AAMI HE75:2009(R)2013 | Human Factors Engineering Human factors engineering |
| FDA Guidance (2016) | Applying Human Factors and Usability Engineering to Medical Devices Guidance on applying human factors and usability engineering to medical devices |
| ISO 14971:2019 | Medical devices - Application of risk management to medical devices Application of risk management to medical devices |
Usability Engineering Process
Our evaluation lab helps manufacturers perform usability evaluations in accordance with the usability engineering process required by IEC 62366-1.
Research Support Services
| Service | Description |
|---|---|
| Expert Consultation |
|
| Benchmarking |
|
| Focus Group Interview |
|
| Heuristic Analysis |
|
| Clinical Environment Observation |
|
| Usability Test – Formative Evaluation |
|
| Usability Test – Summative Evaluation |
|
Evaluation Procedure
Once a usability evaluation is requested, it proceeds in the following order.
KOLAS (Internationally Accredited Testing Laboratory) Accredited Institution
A KOLAS-accredited testing laboratory is an institution that has met the accreditation criteria set by the Korea Laboratory Accreditation Scheme (KOLAS) and the requirements of KS Q ISO/IEC 17025, and has been assessed and accredited as competent to perform testing in the relevant field.
The Institute of Convergence Medicine with Innovative Technology at Seoul National University Hospital has performed medical device usability evaluations as a KOLAS-accredited testing laboratory since its first accreditation in 2018. (Scope of accreditation: (03.010 Medical Devices) / IEC 60601-1-6:2010+AMD1:2013+AMD2:2020, IEC 62366-1:2015+AMD1:2020 5.7–5.9)
The KOLAS accreditation system is expected to guarantee the credibility of testing institutions, enhance the reliability of test reports, and increase the overseas usability of accredited reports through Mutual Recognition Arrangements (MRA).
Contact
Phone
02-2072-4400
Research Support Services
- · Support and consulting related to medical device clinical trials
- · Management of investigational medical devices
- · Training on preparing and managing essential documents for clinical trials (CRC training)
- · Medical device clinical trial CRC duties
Medical Device Clinical Trial Procedure
Full Support for Document Forms Related to Investigational Medical Device Storage
Contact
Phone
02-6072-5367
Research Support Services
- · Guidance and support on procedures required for medical device notification, certification, and approval
- · Guidance and support on preparing technical documentation review materials
- · Guidance and support on reviews such as Good Manufacturing Practice (GMP: quality management) conformity assessment
Certification and Qualification Status
- · First domestic university hospital to obtain a GMP (software product group) conformity certificate
- · Digital medical device manufacturing business license
- · Class 1 and 2 digital medical device manufacturing certification and notification
Medical Device Notification, Certification, and Approval Procedure
Contact
Phone
02-6072-5366