Points for establishing and checking the quality management system for medical device software.
S11242
★We will provide you with the key points to start with in order to ensure quality for manufacturers entering the existing market and the medical device industry!
Speaker Mr. Tsuyoshi Imaseki, President of Imatec Co., Ltd. Target Audience: Engineers, SEs, researchers, etc. interested in medical devices, software, and more. Venue: Kawasaki City Educational and Cultural Center, 3rd Floor, Conference Room 4 [Kanagawa, Kawasaki City] 12 minutes on foot from Kawasaki Station on JR or Keikyu Line. 5 minutes by bus from Kawasaki Station. Date and Time: Tuesday, December 20, 2011, 13:30-16:30 Capacity: 30 people. *Registration will close once full. Please apply early. Participation Fee: [Early Bird Discount Price] 19,950 yen per person (tax included, including text costs) *Limited to Tech-Zone members who apply by December 6. Membership registration is free. *After December 6, the [Regular Price] will be 23,100 yen per person (tax included, including text costs). ◆ When applying for the early bird discount, please select “1 person (early discount)” or “2 people (early discount)” in the number registration.
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basic information
【Lecture Summary】 In recent years, the increasing scale and complexity of software embedded in medical devices have heightened the risk of medical accidents. Various organizations, including the FDA, are establishing standards and regulations; however, the reality is that there is a lack of literacy regarding software on the development side and insufficient experience among stakeholders in quality management, leading to inadequate problem resolution. The number of warnings from the FDA related to software development issues continues to rise. For existing manufacturers and those entering the medical device industry, what must be prioritized to ensure quality? This seminar will provide a clear explanation.
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1. Introduction 1-1 Problem Examples 1-2 Points to Consider in Software Development for Medical Devices 1-3 Differences from Existing Software Quality Management Activities 2. General Principles of Software Validation - Overview 2-1 Scope and Approach of This Guideline 2-2 Principles of Software Validation 2-3 Main Activities and Tasks 2-4 Validation of Manufacturing Facilities and Quality Systems 3. Overview of ISO/IEC 62304 3-1 Scope and Approach of This Standard 3-2 Software Lifecycle Processes and Activities 3-3 Terminology Explanation (Risk, Software Item, SOUP, Traceability) 3-4 Software Development Planning - Requirements Analysis 3-5 Software Architecture Design - Detailed Design 3-6 Software Implementation - Verification 3-7 Software Integration - System Testing 3-8 Configuration Management, Risk Management, Problem Solving 4. Conclusion 4-1 Software Structures Prone to Defects 4-2 Ways to Improve Quality 4-3 Establishing a Quality Assurance System
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