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IMDS School Singapore
Singapore 2024 Agenda
18 - 21 March 2024 GMT+8
Venue: Temasek Polytechnic
Day 2: 19 March 2024
MEDICAL DEVICE DESIGN & DEVELOPMENT, QUALITY MANAGEMENT & STANDARDS
09:00 – 09:30 AM
Registration
09:30 – 09:50 AM
Design Thinking of Medical Device Innovation
09:50 – 10:05 AM
Tea Break
10:00 – 12:00 PM
Design Thinking Workshop:
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Concept brainstorming & Value proposition
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Design requirements, Feasibility vs validation discussion
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Project Management
12:00 – 13:00 PM
Lunch
13:00 – 13:30 PM
Quality Management System - Importance of QMS, Design to Production, Risk management
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What are the key QMS: ISO 13485, MDSAP, QSR, MDR, IVDR
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Design to production requirements
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Design control requirements
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Elements in Design History File
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Risk management in product lifecycle: ISO 14971
13:30 – 13:50 PM
Standards Adoption for Medical Device
13:50 – 14:10 PM
Electrical and Electromagnetic testing
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IEC60601, IEC61010
14:10– 14:30 PM
Software validation, Usability, Software
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IEC62304, IEC62366
14:30 – 14:50 PM
Biocompatibility
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ISO10993
14:50 – 15:10PM
Sterilization & Packaging
15:10 – 15:45 PM
Health safety compliance eg Radiation, Wireless
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Equipment registration requirements for Wireless Medical Devices
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Others (i.e. Packaging reporting, Radiation, etc)
15:45 - 16:05 PM
CEO Session
16:05 – 16:20 PM
Tea Break
16:20 – 18:20 PM
Workshop Regulatory Strategy
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Start-ups getting first approval in US, CE, or local country
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Regulatory strategy compliance for Technical, Clinical, Key requirements for Global approval
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Content of Technical documentation, Clinical Evaluation Report, Country Submission Dossier
18:20 PM
End of Day 2