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IMDS School Singapore
Singapore 2025 Agenda
25 - 28 March 2025 GMT+8
Venue: Temasek Polytechnic
Day 2: 26 March 2025
MEDICAL DEVICE REGULATORY AFFAIRS, DESIGN & DEVELOPMENT,
QUALITY MANAGEMENT & STANDARDS
09:00 – 09:30 AM
Registration
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09:30 – 09:50 AM
Design Thinking of Medical Device Innovation
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09:50 – 10:05 AM
Tea Break
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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
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12:00 – 13:00 PM
Lunch
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13:00 – 13:30 PM
Quality Management System - Importance of QMS, Design to Production, Risk Management & Design Control
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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
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13:30 – 13:50 PM
Standards Adoption for Medical Device
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13:50 – 14:10 PM
Electrical and Electromagnetic Testing
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IEC60601, IEC61010
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14:10 – 14:30 PM
Software Validation, Usability, Software
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IEC62304, IEC62366
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14:30 – 14:50 PM
Biocompatibility
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ISO10993
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14:50 – 15:10PM
Sterilization & Packaging
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15:10 – 15:35 PM
Health Safety Compliance
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Equipment registration requirements for Wireless Medical Devices
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Packaging reporting, Radiation
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15:45 – 16:00 PM
Tea Break​
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16:00 – 17:00 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
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17:00 – 18:00 PM
Wrap-up & Quiz
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18:00 PM
End of Day 2