～Foundation, IEC62304, ISO180001, IEC60601-1～
★ The Concept of Software in the New Pharmaceutical Affairs Law! ★ Key Points and Countermeasures for ISO180001, IEC60601-1, IEC62304 ★ Reading Between the Lines of Standards!? 【Instructor】 Masahiro Sakakibara, Representative of Mono Wellbeing Co., Ltd. Formerly engaged in product safety review operations in the Medical Devices Division of TÜV Rheinland Japan 【Venue】 Tekuno Kawasaki, 5th Floor, Room 5 Training Room【Kanagawa, Kawasaki】 【Date and Time】July 17, 2014 (Thursday) 13:30-16:30
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basic information
【Lecture Summary】 This seminar will provide a clear explanation of the considerations regarding software in the new Pharmaceutical Affairs Law, the standards of ISO 180001, IEC 60601-1, and IEC 62304, as well as the software development process and documentation (including SOUP, development and verification tools, and development methodology considerations), highlighting points that are not easily understood. It is a must-attend seminar for companies considering entering the medical device field.
Price information
Applications received by July 3rd will be 43,200 yen (including tax and text costs) for 2 people from 1 company.
Price range
P2
Delivery Time
P2
Applications/Examples of results
1. Medical Devices, Software, and Safety 1.1 Medical Devices and Software 1.2 Embedded Software and Application Software 1.3 Software and Functional Safety 2. Software in the New Pharmaceutical Affairs Law 2.1 Concept of Software in the New Pharmaceutical Affairs Law 2.2 Software that Became Medical Devices under the New Pharmaceutical Affairs Law 3. Standards Related to Software 3.1 IEC60601-1 3.2 IEC62304 3.3 ISO180001 4. Software Development Process and Documentation (SOUP, Development and Verification Tools, Development Methodology) 4.1 Software Development Plan and Documentation Plan 4.2 Creation of Requirements Specification 4.3 Architecture Design 4.4 Detailed Design 4.5 Implementation and Verification 4.6 Integration Testing 4.7 System Testing 4.8 Release 4.9 Configuration Management 4.10 Problem Solving 4.11 Maintenance [Q&A]
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Our company has developed its business from "seminar planning" to various forms such as "lecturer dispatch," "publishing planning," "technical consultant dispatch," "trend research," "business matching," and "business development consulting," in order to support clients in a wide range of fields including chemistry, electronics, automotive, energy, medical devices, food, and building materials. By doing so, we have advanced our company and opened up new markets. AndTech promises to continue listening to our clients' voices, entering the business areas and markets they desire, and to remain a company that is loved by our clients, as we share their challenges, think together, and forge new paths.