[Hulinks Blog] Risk Management for Medical Devices Using APIS IQ (FMEA): A Case Study of Cardiovascular Catheters

Integrated FMEA software that supports the promotion of quality management and functional safety.

APIS IQ is a standard product in the field of FMEA and risk analysis, having met the high demands of over 2,000 companies worldwide for many years. APIS IQ addresses issues that were difficult to achieve with traditional spreadsheet procedures. Unlike conventional tabular forms of FMEA, it enhances efficiency by clearly defining the relationships between components and processes in a tree structure. [Features] - Fully compliant with the international standard for the automotive industry, AIAG&VDA FMEA - Visualizes causal relationships through a network representation of structure, function, and failure - Mutual synchronization between the network and FMEA sheets - Management and support of documents in 31 languages - Supports automotive international safety standards ISO26262 and IATF16949 - Output functionality for FMEA sheets in AIAG/VDA and DRBFM formats - Statistical functions capable of outputting various statistical graphs - Ability to generate and synchronize process flow diagrams and control plans from PFMEA trees *Product names and other terms are trademarks or registered trademarks of APIS Informationstechnologien GmbH.

• Other production management systems

FMEA - Introduction of Case Studies Using Automated Driving Monitoring Systems

[Steps in APIS IQ] FMEA consists of seven steps. Here, we will focus on the three most important and fundamental steps for conducting FMEA: structural analysis, functional analysis, and failure analysis. 1. Planning and Preparation: FMEA Scope Analysis 2. Structural Analysis: Create a structure tree from the selected system elements 3. Functional Analysis: Describe the "functions" of the system elements and create a function network 4. Failure Analysis: Describe the "failures" corresponding to the functions of the system elements and create a failure network 5. Risk Analysis: Management responsibilities, failure ranking: AIAG/VDA form / AP correspondence 6. Optimization: Measures to mitigate risks: AIAG/VDA form / AP correspondence 7. Documentation: Output and communication of results: AIAG/VDA form For more details, please check below. https://www.hulinks.co.jp/support/apis/gs/index.html

• Process Control System
• Other production management systems

FMEA - Application Example for Cylindrical Lithium-Ion Secondary Batteries

Lithium-ion batteries are high-energy-density secondary batteries used in various fields such as onboard applications for HEVs and EVs, backup for power systems, and storage for renewable energy. As their range of use expands, safety has also become a focus of attention. Particularly, due to the high energy density of the batteries, caution is necessary as internal short circuits and thermal runaway can lead to major accidents. Against this backdrop, the quality of onboard batteries is regulated by the automotive-related standard IATF16949, and when exporting, the submission of documents (FMEA sheets) in accordance with the IATF16949 standard is mandatory. Additionally, for stationary secondary batteries, the safety standard IEC 62619 has been established. There are several shapes of lithium-ion batteries, but here we will explain cylindrical lithium-ion secondary batteries. The components of cylindrical lithium-ion secondary batteries can be broadly classified into eight elements.

• Secondary Cells/Batteries
• Other production management systems

We have added a new **"Glossary"** to the Hyper CLT sheet website. In the civil engineering and construction industries, there are many specialized terms such as "CLT," "NETIS," "temporary roads," and "wooden lightweight sheets." Therefore, we have introduced related terms in an easy-to-understand manner so that those who are encountering Hyper CLT sheets for the first time can understand the products and technologies. Hyper CLT sheets are wooden lightweight sheets for civil engineering that utilize wood CLT and are registered under the Ministry of Land, Infrastructure, Transport and Tourism's NETIS technology as **"TH-250021-A."** We hope that by not only conveying the features of the product but also sharing the underlying technologies and terminology, users will feel a closer connection to Hyper CLT sheets. We will continue to enhance our website and provide clear information related to wood, NETIS, civil engineering, and CLT.

Hotron Inc. has launched its new product, the "Vehicle Count Sensor CCS3"! This product is a ceiling-mounted sensor that combines infrared and radar technology. It reliably detects vehicles in both directions with a single unit, accommodating traffic during congestion and vehicle passing, thus achieving efficient occupancy management in large parking lots. Additionally, it can be utilized for exit warning purposes in addition to vehicle counting, contributing to the safe and smooth operation of parking facilities. 'Features' - Improved detection performance against changes in road surface during rainy weather by using both infrared and radar. - Equipped with IP67 waterproof and dustproof performance, making it effective even in salt damage areas. - Various settings can be configured from a dedicated app (for Android devices), with current settings easily understandable at a glance. - The base dimensions are the same as the previous model "CCS2," allowing for smooth replacement of existing equipment. *For more details, please refer to the product information, catalog download, or contact us.*

On September 15, 2026, we issued a press release regarding the wooden lightweight sheet "Hyper CLT Sheet." The Hyper CLT Sheet is a civil engineering sheet that utilizes CLT (Cross-Laminated Timber) stacked in an orthogonal direction. It can be used in various locations such as temporary roads, access routes, heavy machinery work yards, and material storage areas. The 5×10 version weighs approximately 230 kg, making it relatively lightweight and easy to install, remove, and relocate. Additionally, it offers environmental benefits such as reducing glare and metallic sounds typical of wood, as well as CO2 fixation. Furthermore, it can be proposed for the use of new technologies in public works as a **registered technology with the Ministry of Land, Infrastructure, Transport and Tourism "TH-250021-A."** Through this press release, we aim to expand the new wooden lightweight sheet that combines wood, NETIS, civil engineering, and CLT to more construction sites.

● The production time for cast prototypes can be shortened! Since model making is not required, the production time for prototypes, which previously took about a month, can be significantly reduced. ● Model costs can be reduced! By directly producing sand molds from 3D data, there is no need for model production costs. If changes to the model are necessary, they can be addressed by modifying the 3D data. ● Similar products with different shapes and dimensions can be prototyped simultaneously! Different products, such as similar shapes or varying dimensions, can be molded at the same time in one molding process. This allows for the verification of multiple types in a short period.

The "HA-T Series" is an energy-saving automatic door sensor that opens only for those who wish to enter, whether on a busy street or in a narrow passageway. The automatic door opens simply by bringing your hand close, addressing hygiene concerns even in facilities used by a large number of people. You can choose between "Non-vision Mount Type/HA-T401" and "Non-vision Built-in Type/HA-T520" depending on the application and installation location. 【Recommended for such places!】 ☑ Entrance facing a busy corridor ☑ Presence of counters or signs near the door ☑ Buildings facing narrow passages ☑ Buildings that prioritize aesthetics ☑ Hospitals and facilities that consider hygiene ☑ Large facilities with many doors 【Features】 ● Adaptable to various door types with four detection spot settings ● Reduces unnecessary opening and closing, contributing to energy-saving by minimizing wasteful power consumption ● Equipped with a light touch function, allowing the door to open and close just by waving your hand, ensuring hygiene ● Can also be used as a wide detection range non-vision infrared sensor ◎ For more details, please download the materials or contact us.