IEC 62304-Compliant Mobile App for Accurate Test Interpretation
Project Brief
A biotech company specializing in test kits for UTI, Pregnancy, Ferritin, and Vitamin D needed a mobile app to assist users in accurately interpreting their test results. The app required compliance with IEC 62304 standards to ensure precision and safety in diagnostics. The objective was to empower patients to take proactive measures regarding their health by understanding their results and connecting with healthcare professionals for consultations. Additionally, the app included eCommerce functionality, enabling users to purchase test kits directly from the platform.
Period: Ongoing
Location: Australia
Engagement Model: Time and Material
Project Type: Medical Devices Mobile Application
Location: Australia
Engagement Model: Time and Material
Project Type: Medical Devices Mobile Application
Services Offered
- Documentations required for Safety Class B software as per IEC 62304
- Cross-Platform Mobile App Development
- Advanced Image Processing for accurate test result interpretation
- eCommerce Integration
Technologies Used
Backend: Flask (Python), Microservices Architecture
Frontend: React Native
Database: MySQL
Third-Party Services: OpenCV for image processing, Shopify Mobile Buy SDK, Shopify API for eCommerce integration, AWS S3 for storage, and Firebase for push notifications.
The Problems
Speed Issues
The existing platform suffered from slow application load times and inefficient loan processing speeds, leading to operational delays.
Scalability Challenges
As the user base grew, the system struggled to handle increasing transaction volumes, resulting in performance bottlenecks.
Compliance with Financial Regulations:
- eKYC (Electronic Know Your Customer): Electronic customer verification is required to comply with Anti-Money Laundering (AML) and Combating the Financing of Terrorism (CFT) regulations.
- CKYC (Central Know Your Customer): Needed to centralize KYC processes to improve data accuracy and avoid duplication.
- eNACH (Electronic National Automated Clearing House): Essential for automating recurring payment processing to ensure reliable payment collections.
- eSign: Required for enabling legally valid electronic signatures, reducing reliance on physical signatures.
Compliance with Financial Regulations:
- eKYC (Electronic Know Your Customer): Electronic customer verification is required to comply with Anti-Money Laundering (AML) and Combating the Financing of Terrorism (CFT) regulations.
- CKYC (Central Know Your Customer): Needed to centralize KYC processes to improve data accuracy and avoid duplication.
- eNACH (Electronic National Automated Clearing House): Essential for automating recurring payment processing to ensure reliable payment collections.
- eSign: Required for enabling legally valid electronic signatures, reducing reliance on physical signatures.
Rapid Business Growth
The company needed to integrate with leading Indian banks as financial partners and co-lenders to streamline loan disbursements and onboarding processes.
Security and User Experience
The platform needed enhanced security measures, including IP whitelisting, authentication, authorization protocols, data validation, and encryption of sensitive information.
Financial Reports
Initial reports generated incorrect values due to calculation errors and incomplete data handling, affecting decision-making processes.
The Solution We Created
Initial Assessment
Conducted a thorough analysis of the existing platform to identify performance bottlenecks, security vulnerabilities, and compliance gaps.
Roadmap Development
Created a detailed roadmap to address scalability, speed, security, and regulatory compliance, with clear milestones and timelines.
Live Database Instance
Implemented a new live database instance to distribute the calculation load, enabling the platform to handle increased transaction volumes efficiently.
Indexing Strategies
Employed indexing strategies and optimized queries to improve application load and loan processing times.
Caching Mechanism
Introduced caching mechanisms to enhance response times and reduce database strain.
Regulatory Compliance APIs
Integrated critical APIs for eKYC, CKYC, eNACH, and eSign to ensure seamless onboarding and compliance with regulatory requirements.
Bank Integration
Developed APIs for integration with leading Indian banks for both lender and partner roles to facilitate efficient data transfer and streamlined loan processing.
IP Whitelisting
Applied IP whitelisting to restrict access to approved IP addresses.
Authentication and Authorization
Implemented robust authentication and authorization protocols to verify user identities and manage access levels.
Data Validation and Encryption
Conducted comprehensive data validation and encryption of sensitive information to safeguard user data.
Re-engineering Reports
Reworked the reporting system to correct calculation errors, improve data handling, and provide a comprehensive view of operational metrics.
Updating Data Sources
Updated data sources and refined report logic to ensure accuracy.
Adding Data Points
Incorporated additional data points to provide a more comprehensive and reliable view of the business.
Continuous Monitoring
Set up continuous monitoring to proactively identify and address any emerging issues.
Regular Updates
Provided regular system updates to ensure the platform remained secure, scalable, and compliant with evolving regulations.
Initial Assessment
Conducted a thorough analysis of the existing platform to identify performance bottlenecks, security vulnerabilities, and compliance gaps.
Roadmap Development
Created a detailed roadmap to address scalability, speed, security, and regulatory compliance, with clear milestones and timelines.
Live Database Instance
Implemented a new live database instance to distribute the calculation load, enabling the platform to handle increased transaction volumes efficiently.
Indexing Strategies
Employed indexing strategies and optimized queries to improve application load and loan processing times.
Caching Mechanism
Introduced caching mechanisms to enhance response times and reduce database strain.
Regulatory Compliance APIs
Integrated critical APIs for eKYC, CKYC, eNACH, and eSign to ensure seamless onboarding and compliance with regulatory requirements.
Bank Integration
Developed APIs for integration with leading Indian banks for both lender and partner roles to facilitate efficient data transfer and streamlined loan processing.
IP Whitelisting
Applied IP whitelisting to restrict access to approved IP addresses.
Authentication and Authorization
Implemented robust authentication and authorization protocols to verify user identities and manage access levels.
Data Validation and Encryption
Conducted comprehensive data validation and encryption of sensitive information to safeguard user data.
Re-engineering Reports
Reworked the reporting system to correct calculation errors, improve data handling, and provide a comprehensive view of operational metrics.
Updating Data Sources
Updated data sources and refined report logic to ensure accuracy.
Adding Data Points
Incorporated additional data points to provide a more comprehensive and reliable view of the business.
Continuous Monitoring
Set up continuous monitoring to proactively identify and address any emerging issues.
Regular Updates
Provided regular system updates to ensure the platform remained secure, scalable, and compliant with evolving regulations.
Results
Increased Efficiency
Significantly reduced loan processing and application load times, leading to an enhanced user experience.
Enhanced Security
Strengthened security protocols, including IP whitelisting, authentication, authorization, data validation, and encryption
Scalability
The platform now efficiently handles a growing number of monthly loan disbursements.
Regulatory Compliance
Achieved full compliance with financial regulations through the integration of eKYC, CKYC, eNACH, and eSign APIs.
Ready to Get Started?
Are you looking to overcome performance challenges or ensure regulatory compliance in your financial platform? Tech Exactly specializes in building scalable, secure, and efficient solutions tailored to your business needs. Reach out to us today to learn how we can help drive your success.
