Case Studies for ISO 13485 - GMP - QMSR

Standard: 21 CFR 820 (QMSR)
Scope of the Manufacturer: Design, Development, Manufacturing, and Distribution of Dental Devices 
Device Type: Non-Sterile 
Project Start Date: May 2024
Project End Date: March 2025

Standard: ISO 13485
Scope of the Manufacturer: Design, Development, Manufacturing, Testing and Distribution 
Device Type: Sterile 
Project Start Date: September 2022
Project End Date: March 2023

Standard: IEC 62304
Scope of the Manufacturer: Design, Development, Manufacturing, Testing, Integration and Distribution 
Device Type: Software Device 
Project Start Date: October 2024
Project End Date: July 2025

Standard: EN ISO 13485 + IEC 62304
Scope of the Manufacturer: Design, Development, Manufacturing, Testing and Distribution 
Device Type: Software Device 
Project Start Date: March 2024
Project End Date: February 2025

Standard: EN ISO 13485 + IEC 62304
Scope of the Manufacturer: Design, Development, Manufacturing, Testing and Distribution of Blood Glucose Monitoring System and Accessories 
Device Type: Hardware + Firmware 
Project Start Date: March 2023
Project End Date: April 2024