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Device and Systems Integration into Existing LIS
about project
The set of projects involved a series of integrations between various laboratory devices and the customer's existing Lab Information System (LIS). The primary objective was to ensure seamless communication between the devices and the customer’s software, enhancing data handling, device control, and workflow automation.
Drivers were developed for each device, along with software updates to the customer’s existing application. In some cases, simulators were created to facilitate testing and debugging without the need for physical devices.
Devices involved in the project:
- Qinstruments Bioshaker (different types)
- Magellan Devices: Hydroflex Washer and F50 Reader
- Inheco Teleshake 95 AC
- Inheco Incubator
- Inheco ODTC (On-Deck Thermal Cycler)
- aBPS
- Mettler Balance
- Waterbath
- Barcode Scanner
- Micro-Sized Barcode Imager
tasks
01
01
DEVELOP DEVICE DRIVERS
Create drivers for the devices to ensure seamless integration with the existing LIS/MIS/HIS software ecosystem.
02
02
SOFTWARE UPDATES AND INTEGRATION
Implement necessary updates to the customer’s application to support the new devices.
03
03
DEVICE SIMULATION
Develop simulators for the devices to enable testing and debugging without requiring physical hardware.
03
03
04
04
DEVICE AND SYSTEM INTEGRATION
Ensure smooth communication between the devices and the existing systems using standardized protocols.
05
05
TESTING AND VERIFICATION
Produce a full documentation package, conduct thorough testing and verification and ensure the entire system meets IEC 62304 standards for medical device software.
06
06
07
07
08
08
Results
COMPLETE INTEGRATION
All devices were successfully integrated into the customer’s system, meeting all performance and compatibility requirements.
SIMULATORS ENABLED EFFICIENT TESTING
The simulators provided an efficient way to test and debug the devices, reducing dependency on physical hardware during development.
IMPROVED LAB EFFICIENCY
The integration allowed the customer to significantly reduce laboratory processing times, thanks to enhanced automation capabilities.
COMPLIANCE WITH IEC 62304
The entire integration process, including development, testing, and verification, was in full compliance with the IEC 62304 standard for medical device software.
process
Requirements Gathering and Planning
Collaborated with the customer to gather detailed integration requirements and planned the updates for both devices and systems.
Driver Development and Software Updates
Developed software modules to support the seamless operation of devices within the customer’s ecosystem.
Device Simulation
Created device simulators to test various integration scenarios and debug without the need for physical devices, ensuring reliability before deployment.
Testing, Verification, and Validation
Performed extensive testing and verification with simulators and physical devices to confirm that the integration met all performance, compatibility, and safety requirements in compliance with IEC 62304.
Deployment and Customer Approval
Deployed the solution within the agreed timeframe, with the customer approving the integration for all devices.
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contacts
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IEC 62304
ISO 13485
ISO 9001
APR-4761
APR-4754A
DO-254
DO-248
DO-178
DO-330
DO-297
DO-331
DO-332
DO-333
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