Patient Portal Development Services | Custom Healthcare Portal Solutions

Custom patient portal development company delivering HIPAA compliant, secure healthcare patient portal solutions with EHR integration, appointment scheduling, and billing.

HIPAA Compliant Software Development

Comprehensive Medical Device Software Development

Expert development of FDA-compliant, CE-marked software for medical devices across all classification levels

Software as a Medical Device (SaMD)

Standalone medical software development
Cloud-based SaMD platforms
Mobile medical applications
AI/ML diagnostic algorithms
Clinical decision support systems
Remote patient monitoring software

Embedded Medical Device Software

Real-time operating system (RTOS) development
Firmware for medical equipment
Device driver development
Hardware-software integration
Microcontroller programming
Low-level system optimization

FDA 510(k) Software Development

Predicate device analysis
Substantial equivalence documentation
510(k) submission preparation
Software validation protocols
FDA audit support
Post-market surveillance systems

Class II Medical Device Software

Moderate-risk device software
Diagnostic imaging software
Patient monitoring systems
Infusion pump controllers
ECG analysis software
Blood glucose monitoring apps

Class III Medical Device Software

High-risk life-sustaining devices
Implantable device software
Pacemaker control systems
Defibrillator algorithms
Cardiac ablation systems
PMA submission support

Wearable Medical Device Software

Continuous monitoring wearables
Fitness tracker medical features
Smart patch applications
Biosensor data processing
Real-time health alerts
Cloud connectivity integration

Need FDA-Compliant Medical Device Software?

Schedule a consultation with our regulatory and software development experts

Get Expert Consultation

Regulatory Compliance & Standards Expertise

Full compliance with international medical device software regulations and quality standards

IEC 62304 Medical Device Software Lifecycle

Software safety classification (Class A, B, C)
Software development planning documentation
Software requirements specification (SRS)
Architectural and detailed design documentation
Software unit implementation and verification
Software integration and integration testing
Software system testing protocols
Software release and version control
Software maintenance and problem resolution
Risk management per ISO 14971
Configuration management procedures
Change control and impact analysis

ISO 13485 Quality Management System

Quality management system establishment
Design and development controls
Document and record management
Supplier and vendor management
Production and service provision controls
Measurement, analysis and improvement
Internal audit procedures
Corrective and preventive actions (CAPA)
Management review processes
Traceability requirements
Risk management integration
Post-market surveillance systems

FDA Compliance Requirements

21 CFR Part 11 electronic records compliance
Design control requirements (21 CFR 820.30)
Software validation guidance compliance
Cybersecurity premarket guidance
Off-the-shelf software documentation
Level of Concern (LOC) determination
Software bill of materials (SBOM)
Premarket notification (510k) preparation
Premarket approval (PMA) support
De Novo classification requests
Quality system regulation (QSR) compliance
Medical device reporting (MDR) systems

CE Marking & EU MDR Compliance

EU Medical Device Regulation (MDR 2017/745)
In-Vitro Diagnostic Regulation (IVDR 2017/746)
Technical documentation preparation
Clinical evaluation reports
Post-market surveillance planning
Notified Body engagement support
Unique Device Identification (UDI)
Declaration of conformity
EUDAMED database registration
Vigilance and field safety corrective actions
EU authorized representative services
Essential requirements checklist

Medical Device Software Development Lifecycle

Structured IEC 62304-compliant development process ensuring regulatory approval and patient safety

1

Planning & Requirements

Software development plan creation
Intended use definition
User needs analysis
Risk management planning
Regulatory strategy development
Requirements traceability matrix

2

Architecture & Design

System architecture design
Software architecture specification
Interface design documentation
Database schema design
Security architecture planning
Design review and approval

3

Implementation & Coding

Coding standards compliance
Unit development and testing
Code review procedures
Version control management
Static code analysis
Peer review documentation

4

Verification & Validation

Software verification testing
Integration testing protocols
System validation procedures
User acceptance testing
Regression testing
Traceability verification

5

Risk Management

Hazard analysis (ISO 14971)
Risk assessment and evaluation
Risk control measures
Residual risk evaluation
Risk-benefit analysis
Risk management report

6

Regulatory Submission

Technical file compilation
Software documentation package
Submission to regulatory bodies
Audit and inspection support
Clearance/approval assistance
Post-market compliance

Ready for FDA Clearance?

Let our experts guide you through the complete medical device software development and approval process

Request Project Assessment

Medical Device Software Technology Stack

Advanced technologies and platforms for developing secure, reliable medical device software

Core Development Technologies
                         Programming Languages
                        C/C++ for embedded systems
Python for AI/ML algorithms
Java for enterprise applications
Swift/Kotlin for mobile apps
Assembly for low-level control
MATLAB for algorithm development

                    

                         AI/ML Frameworks
                        TensorFlow for deep learning
PyTorch for neural networks
Scikit-learn for ML models
OpenCV for image processing
Keras for rapid prototyping
ONNX for model deployment

                    

                         RTOS Platforms
                        FreeRTOS for microcontrollers
VxWorks for critical systems
QNX for safety-critical apps
ThreadX for IoT devices
Embedded Linux variants
Zephyr RTOS

                    

                         Security Technologies
                        Hardware encryption modules
Secure boot implementation
Authentication protocols
Network security layers
Data encryption standards
Penetration testing tools

                    

IoT Connectivity

Cloud Platforms

Medical Databases

Wireless Protocols

Mobile SDKs

Analytics Engines

Medical Device Software Solutions by Type

Specialized software development for diverse medical device categories and applications

Implantable Device Software

Cardiac pacemaker programming
Implantable cardioverter defibrillators (ICDs)
Neurostimulation device controllers
Cochlear implant processors
Drug delivery pump systems
Spinal cord stimulators
Deep brain stimulation devices
Continuous glucose monitors (CGM)

Wearable Medical Devices

ECG monitoring patches
Blood pressure monitoring wearables
Pulse oximetry devices
Temperature monitoring sensors
Activity and fall detection
Sleep apnea monitoring
Muscle stimulation devices
Smart medication adherence trackers

Diagnostic Imaging Software

CT scan image processing
MRI analysis algorithms
Ultrasound imaging software
Digital radiography systems
PACS integration solutions
3D reconstruction software
AI-powered anomaly detection
DICOM viewer applications

Therapeutic Device Software

Infusion pump controllers
Dialysis machine software
Ventilator control systems
Radiation therapy planning
Surgical robot controllers
Laser treatment systems
Electrosurgical unit software
Phototherapy device controllers

In-Vitro Diagnostic Software

Laboratory analyzer software
Point-of-care testing devices
Molecular diagnostic systems
Blood glucose meter software
Genetic testing platforms
Immunoassay analyzers
Pathology imaging systems
Clinical chemistry analyzers

Monitoring & Vital Signs

Multi-parameter patient monitors
Cardiac telemetry systems
Fetal monitoring devices
Anesthesia monitoring software
Central station monitoring
Ambulatory BP monitors
Holter monitor analysis
Remote ICU monitoring platforms

Medical Device Software Validation & Testing

Comprehensive verification and validation protocols ensuring safety, efficacy, and regulatory compliance

Software Verification Activities

Requirements verification against specifications
Design verification through peer reviews
Code verification via static analysis tools
Unit testing with 100% code coverage targets
Integration testing of software modules
Interface testing for external systems
Performance and stress testing
Usability testing with representative users
Regression testing for software changes
Automated testing framework implementation
Traceability matrix verification
Test report documentation and review

Software Validation Protocols

Installation qualification (IQ) procedures
Operational qualification (OQ) testing
Performance qualification (PQ) validation
Clinical validation studies
User acceptance testing protocols
Environmental and EMC testing
Software reliability testing
Fault injection and failure mode testing
Interoperability validation
Data integrity validation
Validation master plan development
Validation summary reports

Quality Assurance Testing

Functional testing against requirements
Non-functional testing (performance, scalability)
Security penetration testing
Compatibility testing across platforms
Localization and internationalization testing
Accessibility testing (WCAG compliance)
Load and stress testing protocols
Boundary value and equivalence testing
Negative testing and error handling
System integration testing
Alpha and beta testing programs
Defect tracking and resolution

Cybersecurity Validation

Threat modeling and risk assessment
Vulnerability scanning and penetration testing
Authentication and authorization testing
Encryption validation and key management
Network security testing
Secure boot and firmware integrity verification
Data protection testing (at rest and in transit)
Incident response procedure validation
Patch management process verification
Third-party component security analysis
SBOM (Software Bill of Materials) generation
FDA cybersecurity guidance compliance

Medical Device Software Development Excellence

100% FDA Clearance Success Rate

75+ Medical Devices Developed

20+ Years Industry Experience

Zero Safety-Related Field Actions

Accelerate Your Medical Device to Market

Partner with our FDA-compliant medical device software development experts

Discuss Your Device Project

Medical Device Connectivity Solutions

Interoperable medical device integration enabling data exchange and remote monitoring capabilities

Device Interoperability

HL7 FHIR device data exchange
IEEE 11073 PHD protocols
Continua Health Alliance standards
IHE medical device integration
DICOM connectivity for imaging
Bluetooth Medical Device Profile
USB medical device class
Zigbee healthcare applications

Wireless Communication

Bluetooth Low Energy (BLE) 5.0+
Wi-Fi 6 medical applications
Cellular (4G/5G) connectivity
LoRaWAN for long-range IoT
NFC for device pairing
RFID for asset tracking
Mesh networking protocols
Satellite communication backup

Cloud Integration

AWS for Healthcare compliance
Azure Health Data Services
Google Cloud Healthcare API
HIPAA-compliant data storage
Real-time data streaming
Edge computing integration
API gateway management
Scalable data architecture

Comprehensive Software Documentation

Complete technical and regulatory documentation packages for medical device submissions

Technical Documentation

Software Requirements Specification (SRS)
Software Design Specification (SDS)
Software Architecture Document (SAD)
Interface Control Documents (ICD)
Database Design Specification
Algorithm Description Documents
User Interface Specifications
API Documentation and Reference
Source Code Documentation
Configuration Management Plan
Software Development Plan (SDP)
Traceability Matrix (RTM)

Regulatory Documentation

Software Validation Plan and Report
Software Verification Plan and Report
Risk Management File (ISO 14971)
Software Safety Classification
Clinical Evaluation Report
Usability Engineering File
Cybersecurity Documentation
Post-Market Surveillance Plan
Software Maintenance Plan
Design History File (DHF)
Device Master Record (DMR)
Technical File for CE Marking

Test Documentation

Test Plans and Strategies
Test Cases and Procedures
Test Protocols (IQ, OQ, PQ)
Test Scripts and Automation Code
Test Execution Records
Test Summary Reports
Defect Reports and Resolution
Regression Test Reports
Performance Test Results
Security Test Findings
Validation Summary Report
Test Traceability Matrix

User Documentation

Instructions for Use (IFU)
User Manuals and Guides
Quick Start Guides
Installation Manuals
Service and Maintenance Manuals
Troubleshooting Guides
Training Materials
Video Tutorials
Online Help Systems
Safety Information and Warnings
Release Notes and Change Logs
FAQ Documentation

Post-Market Support & Maintenance

Ongoing support ensuring continued compliance, safety, and performance throughout device lifecycle

Software Maintenance Services

Corrective maintenance for bug fixes
Adaptive maintenance for environmental changes
Perfective maintenance for enhancements
Preventive maintenance and optimization
Emergency hotfix deployment procedures
Patch management and security updates
Version upgrade planning and execution
Legacy system migration support
End-of-life product management
24/7 technical support availability
Remote diagnostics and troubleshooting
Spare parts and component management

Post-Market Surveillance

Complaint handling and investigation
Medical Device Reporting (MDR) to FDA
Vigilance reporting for EU markets
Adverse event monitoring and analysis
Field safety corrective actions (FSCA)
Product recall management
Customer feedback collection and analysis
Performance metrics tracking
Trend analysis and statistical reporting
Periodic safety update reports (PSUR)
Post-market clinical follow-up (PMCF)
Risk-benefit reassessment

Continuous Improvement

Software update planning and deployment
Feature enhancement roadmapping
Performance optimization initiatives
User experience improvements
Technology stack modernization
Regulatory requirement updates
Standards compliance maintenance
Cybersecurity posture enhancement
Interoperability expansion
Cloud infrastructure optimization
AI/ML model retraining
Competitive feature analysis

Cybersecurity Management

Vulnerability monitoring and assessment
Security patch deployment
Threat intelligence integration
Incident response and remediation
Penetration testing (annual/biannual)
Security audit support
SBOM updates and maintenance
Third-party component monitoring
Cryptographic algorithm updates
Access control review and updates
Security training for staff
FDA cybersecurity guidance compliance

Why Choose Our Medical Device Software Development Company

Proven expertise delivering FDA-cleared, CE-marked medical devices with zero safety recalls

Regulatory Expertise

20+ years FDA submission experience
100% clearance success rate
IEC 62304 certified developers
ISO 13485 compliant processes
EU MDR/IVDR expertise
Direct FDA audit experience

Clinical Understanding

Medical device domain experts
Clinical workflow knowledge
Physician advisors on staff
Biomedical engineering team
Patient safety focus
Usability engineering expertise

Technical Excellence

Embedded systems specialists
AI/ML algorithm development
Cybersecurity certified engineers
Cloud architecture experts
IoT integration specialists
Mobile app development team

Quality Assurance

Dedicated QA team
Automated testing frameworks
100% requirements traceability
Independent verification
Risk-based testing approach
Continuous quality monitoring

Cost Efficiency

Fixed-price project options
Transparent pricing models
Optimized development cycles
Reusable component libraries
Efficient regulatory processes
ROI-focused development

Partnership Approach

Dedicated project managers
Agile development methodology
Regular status updates
Flexible engagement models
Long-term support commitment
Knowledge transfer programs

Medical Device Software Development