Software Solution

OUR EXPERTISE

At IZiel, we provide comprehensive software solutions for medical devices, combining technical excellence with regulatory compliance to deliver safe, effective, and innovative products.

SOFTWARE / FIRMWARE DESIGN

Cross Platform AI Enabled Applications
RTOS/ Bare Metal Firmware
Device drivers/ Hardware integration

SOFTWARE VALIDATION

Software Safety Classification
Risk-Driven Technical Files including traceability
Multifunction Device Validation

CSV/ TOOL VALIDATION

Enterprise, Manufacturing, AI & COTS tools
IQ / OQ / PQ Requirements and Testing
Periodic Review and Revalidation

CYBERSECURITY

Compliance with global standards
Threat Model Analysis for security risk management
Vulnerability & Penetration Testing

TEST AUTOMATION

Software Applications & Processes
Test Integration with CI/ CD pipelines
Test coverage Tools utilization

CLOUD IoT INTEGRATION

AI driven data analytics and predictions
Real time data exchange
Composable Platform

DIGITAL TRANSFORMATION

Digital Technology Roadmap Creation
Data Analytics & Dashboards
AI in Manufacturing Quality & Operations

IT SERVICES

Project, Program & Service Management
MES Integration
IT Support & Maintenance

UI/ UX

Design support for SaMD & SiMD
Perception, Cognition & Action (PCA) based task analysis
Summative Testing of critical task

IZIEL AI TOOLS FOR QARA

Multi Facility Audits
Supplier Quality Audits
Record Generation & Score Tracking

CASE STUDIES

Portable Bluetooth Enabled Digital Spirometer

FDA 510(k) Clearance

The Digital Spirometer is designed for both home and clinical use, helping test lung function for users aged 22 and above.

CHALLENGES

Multiple subsystems needing synchronized validation
Risk of failures across firmware, app, and cloud
Strict FDA, IEC, ISO standards to meet

IZIEL APPROACH

Defined Software Requirements Specifications (SRS) aligned with user needs and intended use
Developed structured validation framework
Classified software safety levels & FDA DocLevel
Evaluated SOUP libraries for failures
Created usability validation protocols
Functional unit tests
Integration tests for firmware-app communication
Simulated fault injections to evaluate alarm performance
Analyzed critical user tasks using FMEA

ACHIEVEMENTS

Mitigated 700+ Failure Modes
Enabled Seamless Device-App-Cloud Data Flow
Enhanced Software Quality and Safety
Achieved Successful FDA 510(k) Clearance

Digital X-Ray Imaging System

Cybersecurity Framework

It is an advanced medical imaging technology that offers faster image acquisition, enhanced image quality, and immediate viewing, enabling quicker diagnosis and treatment.

CHALLENGES

FDA's "Content of Premarket Submissions for Cybersecurity" guidance
AAMI TIR57 (Principles for medical device security risk management)
ISO / IEC 27001; 80001 for healthcare IT environments

IZIEL APPROACH

RISK ASSESSMENT & ARCHITECTURE DESIGN
Identified assets, communication flows, and potential threats
Classified threats using STRIDE
Evaluated safety impacts and third-party (SOUP) vulnerabilities via NVD
Created architecture views (Global, Use Case, Multi-Patient Harm, Patch) for full product lifecycle to guide risk assessment
SECURITY IMPLEMENTATION & VERIFICATION
Applied controls: authorization, encryption, audit trails
Verified security measures across the development lifecycle
Compiled SBOM for third-party component tracking
TESTING & MONITORING
Conducted penetration testing, port scans, and privilege escalation simulations
Established post-market update and incident response strategies
REGULATORY DOCUMENTATION & FDA SUPPORT
Delivered a comprehensive Cybersecurity Risk Report for 510(k) submission, including test results and surveillance plans