Case Studies for ISO 13485 - GMP - QMSR
Walk through real ISO 13485, QMSR and IEC 62304 projects delivered by I3CGlobal, slide by slide. Select a project to see how it was delivered.
QMSR – Dental Devices
Scope: Design, Development, Manufacturing, and Distribution of Dental Devices
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- Standard
- 21 CFR 820 (QMSR)
- Device Type
- Non-Sterile
- Project Tenure
- May 2024 – Mar 2025
ISO 13485 – Sterile Devices
Scope: Design, Development, Manufacturing, Testing and Distribution
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- Standard
- ISO 13485
- Device Type
- Sterile
- Project Tenure
- Sep 2022 – Mar 2023
IEC 62304 – Software Device
Scope: Design, Development, Manufacturing, Testing, Integration and Distribution
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- Standard
- IEC 62304
- Device Type
- Software Device
- Project Tenure
- Oct 2024 – Jul 2025
ISO 13485 + IEC 62304 – Software Device
Scope: Design, Development, Manufacturing, Testing and Distribution
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- Standard
- EN ISO 13485 + IEC 62304
- Device Type
- Software Device
- Project Tenure
- Mar 2024 – Feb 2025
ISO 13485 + IEC 62304 – Blood Glucose Monitoring System
Scope: Design, Development, Manufacturing, Testing and Distribution of Blood Glucose Monitoring System and Accessories
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- Standard
- EN ISO 13485 + IEC 62304
- Device Type
- Hardware + Firmware
- Project Tenure
- Mar 2023 – Apr 2024
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