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

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ISO 14971 is an international standard for the systematic management of risks related to medical devices. APIS IQ-Software is one of the representative tools that supports risk analysis in FMEA and ISO 14971. Originally developed as a tool for the automotive industry, it can also be utilized for risk management in medical devices. In this article, we will specifically explain a series of processes for efficient implementation. □Risk Management for Medical Devices (FMEA) Using APIS IQ□ (Visit the HuLinks blog page) https://www.hulinks.co.jp/2026/06/24/apis-iq-medical-devices/ □Please also check related products and catalogs□

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Streamlining Failure Analysis: Quality Management Software 'APIS IQ'
Integrated FMEA software that supports the promotion of quality management and functional safety.

[Basic Information] Other Features - Prevention of omissions through copy & paste of sheets - Tracking of items due to design derivations and design changes - Correspondence of different FMEA forms based on destination and business partners - Centralized management of mandatory items according to various standards - Absorption of variations in wording by input personnel - Standardization of data across various quality management methods and tools other than FMEA - Support for communication with overseas business partners (clarification of procedures) [APIS IQ 8.0 New Features] - Function enhancement: "Failure Naming Patterns" - More user-friendly AIAG/VDA form design - Improvement of management reports - Individually obtainable calculation strategies (FuSa) - New import and update options for FMEDA parameters within forms - Strengthening of variant permissions - Efficient and secure management via CDM Server, etc. https://www.hulinks.co.jp/software/quality/apis/section02/section01#s03 *For more details, please refer to the PDF materials or feel free to contact us.
Introduction to FMEA Using APIS IQ
FMEA - Introduction of Case Studies Using Automated Driving Monitoring Systems

[Basic Information] Other Features - Prevention of omissions through copy and paste of sheets - Tracking of items due to design derivations and design changes - Correspondence of different FMEA forms based on destination and client - Centralized management of mandatory items in accordance with various standards - Absorption of variations in wording by input personnel - Standardization of data across various quality management methods and tools other than FMEA - Support for communication with overseas clients (clarification of procedures) [APIS IQ 8.0 New Features] - Function enhancement: "Failure Naming Patterns" - More user-friendly AIAG/VDA form design - Improvement of management reports - Individually obtainable calculation strategies (FuSa) - New import and update options for FMEDA parameters within forms - Strengthening of variant permissions - Efficient and secure management via CDM Server, etc. https://www.hulinks.co.jp/software/quality/apis/section02/section01#s03 *For more details, please refer to the PDF document or feel free to contact us.
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[Basic Information] Other Features - Prevention of omissions through copy & paste of sheets - Tracking of items due to design derivations and design changes - Correspondence of different FMEA forms based on destination and business partners - Centralized management of mandatory items in accordance with various standards - Absorption of variations in wording by input personnel - Standardization of data across various quality management methods and tools other than FMEA - Support for communication with overseas business partners (clarification of procedures) [APIS IQ 8.0 New Features] - Function enhancement: "Failure Naming Patterns" - More user-friendly AIAG/VDA form design - Improvement of management reports - Individually obtainable calculation strategies (FuSa) - New import and update options for FMEDA parameters within forms - Strengthening of variant permissions - Efficient and secure management via CDM Server, etc. https://www.hulinks.co.jp/software/quality/apis/section02/section01#s03 *For more details, please refer to the PDF document or feel free to contact us.