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IMDS School Singapore

Singapore 2023 Agenda

27 - 30 March 2023 GMT+8

Venue: Temasek Polytechnic

Day 2: 28 March 2023

MEDICAL DEVICE DESIGN & DEVELOPMENT, QUALITY MANAGEMENT & STANDARDS

 

09:00 – 09:30 AM

Registration

09:30 – 10:00 AM

Design Thinking of Medical Device Innovation

10:00 – 12:00 PM

Design Thinking Workshop:

  • Concept brainstorming & Value proposition

  • Design requirements, Feasibility vs validation discussion

  • Project Management

12:00 – 13:00 PM

Lunch

13:00 – 13:30 PM

Quality Management System - Importance of QMS, Design to Production, Risk management

  • What are the key QMS: ISO 13485, MDSAP, QSR, MDR, IVDR

  • Design to production requirements

  • Risk management in product lifecycle: ISO 14971

13:30 – 13:50 PM (Timing)

Standards Adoption for Medical Device

13:50 – 14:10 PM

Electrical and Electromagnetic testing

  • IEC60601, IEC61010

14:10– 14:30 PM

Software validation, Usability, Software

  • IEC62304, IEC62366

14:30 – 14:50 PM

Biocompatibility

  • ISO10993 

14:50 – 15:10PM

Sterilization & Packaging

15:10 – 15:30 PM

Health safety compliance eg Radiation, Wireless

15:30 – 15:50 PM

Tea break

15:50 – 17:50 PM

Workshop Regulatory Strategy

  • Start-ups getting first approval in US, CE, or local country

  • Regulatory strategy compliance for Technical, Clinical, Key requirements for Global approval

  • Content of Technical documentation, Clinical Evaluation Report, Country Submission Dossier

17:50 – 18:05 PM

Quiz

18:05 PM

End of Day 2

 

Topics and Speakers are subjected to change

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