Driving Business Success with Transformative QA solutions in Wearable MedTech
Location
US
Industry
MedTech
Year
2024
Overview
The client is a global leader in medical device manufacturing, committed to developing cutting-edge technologies that empower individuals to manage their health. Their innovative wearable wireless device enables healthcare providers and patients to monitor, record, and analyze vital signs while providing real-time safety alerts, offering enhanced control and proactive healthcare management.
Challenges
Issues
Direct Business Challenge
Regulatory Compliance
- Effective risk assessment
- Adherence to standards
- Documentation
Data
- Data Security
- Data collection and Monitoring
User Experience
- Battery Draining
- Firmware Updates
- Connectivity
Qualizeal’s strategic & tactical solutions
Impact
Strategic & Tactical Solutions
Regulatory Compliance Assurance
QualiZeal’s Medical Devices QARA team conducted a thorough gap analysis, facilitated comprehensive risk assessments, supported tool validation, and ensured compliance with industry standards. The team also streamlined documentation to align with stringent regulatory requirements, ensuring full regulatory assurance.
Validation and End-to-End Test Automation
Leveraging QualiZeal’s automated IoT test framework accelerator, the team rapidly transitioned from manual testing to fully automated, end-to-end testing for on-target devices. They employed advanced algorithm validation techniques, customized simulators/emulators to address interoperability and scalability challenges, and implemented data encryption and integrity checks.
User-Centric System Testing
QualiZeal developed power consumption testing integrated with CI/CD pipelines, ensuring reliable firmware updates. The team also utilized accelerators for interface testing, conducted usability assessments, and performed field tests to enhance the overall user experience.
Value Delivered
Improved User Satisfaction
0
%
Improved Data Accuracy
0
%
Improved Energy Efficiency
0
%
Reduced Time to Market
0
%
