Your Trusted Partner for Developing IEC 62304-Compliant Medical Device Software
Tech Exactly supports MedTech companies with medical device development services focused on safety, scalability, and regulatory compliance. Our healthcare product engineering teams design and build compliant medical technology that aligns with IEC 62304 requirements and real-world clinical use. We help organizations reduce development risk, maintain quality standards, and deliver dependable medical software with confidence.
Top Rated
Clients
Why Choose Tech Exactly
Tailored medical technology for hospitals, clinics, and health-tech companies.
- End-to-End Medical Device Development
- Compliance-First Engineering
- Expertise in Connected Medical Technology
- Custom Solutions Built to Scale
Transforming Businesses with Proven Results
Faster development, greater efficiency, trusted globally, and driven by referrals.
savings with AI-powered Engineering
users trust our products
efficiency boost for businesses
of new clients come from referral
Comprehensive Solutions for SaMD and SIMD Development
From Mobile Apps to AI and Cybersecurity, We Deliver End-to-End Services to Build Secure, Compliant, and Innovative Medical Software
Mobile App Development
Crafting compliant and patient-friendly mobile apps for medical devices, enhancing accessibility and usability in healthcare.
API Development
Designing secure, interoperable APIs that enable seamless data exchange and integration with healthcare systems and medical devices.
AI/ML Services
Implementing AI and ML solutions to support diagnostic accuracy, predictive analytics, and personalized patient care in medical devices.
Wearable App Development
Developing wearable-compatible applications for real-time health monitoring and data collection, ensuring compliance with healthcare standards.
Cloud Deployment
Leveraging scalable cloud infrastructure for medical software, ensuring high performance, data security, and regulatory compliance.
Cybersecurity Services
Providing robust cybersecurity solutions to protect sensitive medical data and device functionality against evolving threats.
Technologies We Use
Helping startups and enterprises with the right blend of experience and technology
Backend
We only use scalable, reliable, secure, and performant backend technologies to power our client’s digital products.
Nodejs
Python
Dot Net
PHP
Frontend
Our suite of web front-end technologies offers a delightful user experience.
Angular
React
Vue
JavaScript
jQuery
Mobile
To support our customer’s business we only use technologies that are reliable and have a strong community.
Kotlin
Swift
ReactNative
Flutter
Database
Modern databases that are reliable, fast, secure, and widely accepted.
Postgres
MongoDB
MySQL
SQL Server
Backend
We only use scalable, reliable, secure, and performant backend technologies to power our client’s digital products.
Frontend
Our suite of web front-end technologies offers a delightful user experience.
Mobile
To support our customer’s business we only use technologies that are reliable and have a strong community.
Database
Modern databases that are reliable, fast, secure, and widely accepted.
Achieving Compliance with Confidence
A Structured, Reliable Approach to Building Safe and Effective Medical Software
Creating compliant medical device software requires a careful balance of technical precision, adherence to global standards, and patient-centered design. Here’s how Tech Exactly’s comprehensive process ensures safety, effectiveness, and regulatory compliance every step of the way:
Software Safety Classification: Laying a Compliance-Driven Foundation
Every project begins with creating a classification matrix that identifies acceptable risks and classifies software safety under IEC 62304 guidelines. By categorizing your software as Class A, B, or C, we align design, testing, and verification requirements to the necessary safety standards.
Requirements Analysis: Documenting Needs with Clarity and Precision
Requirements capture functional, safety, and user needs to define clear, traceable expectations that inform design and implementation.
Structured Architectural Design: Building a Robust, Scalable Software Architecture
Our architecture is structured to streamline testing and future updates, enhancing maintainability and traceability. Our design is informed by ISO 14971 guidelines to identify and mitigate risks by design. Each module and data flow prioritizes safety, reliability, and regulatory compliance.
Rigorous Implementation with Code Quality Checks
Our coding standards include robust risk controls, particularly for safety-critical functions, to meet IEC 62304 requirements and deliver consistent performance. We implement peer-to-peer code reviews to maintain high-quality, error-free code, allowing each developer to assess and optimize their peers' work.
Comprehensive Risk Management Aligned with ISO 14971
Tech Exactly actively applies ISO 14971 guidelines to perform hazard analysis, assessing potential risks at each development stage. We maintain a comprehensive risk management file to document identified risks, mitigations, and safety controls for each phase of development.
Thorough Verification & Validation (V&V) for Quality Assurance
We conduct unit, integration, and system testing to verify that every component and function operates as intended and integrates seamlessly. We leverage IEC 62366 guidelines to ensure a user-friendly interface and intuitive instructions for use, optimizing both the user experience and patient safety.
Meticulous Configuration Management for Consistency
We monitor all software versions and document changes, ensuring full traceability and consistent performance across updates. Every modification is carefully logged, reviewed, and tracked to prevent unauthorized changes and maintain the software’s integrity.
Post-Release Support & Problem Resolution: Your Partner Beyond Launch
Proactive Monitoring and Maintenance: Post-launch, we provide ongoing support, tracking performance, addressing issues, and keeping the software compliant and up-to-date. As regulations and technology evolve, we’re here to help you keep pace, ensuring your software is always ready for future advancements.
Every project begins with creating a classification matrix that identifies acceptable risks and classifies software safety under IEC 62304 guidelines. By categorizing your software as Class A, B, or C, we align design, testing, and verification requirements to the necessary safety standards.
Software Safety Classification: Laying a Compliance-Driven Foundation
Requirements capture functional, safety, and user needs to define clear, traceable expectations that inform design and implementation.
Requirements Analysis: Documenting Needs with Clarity and Precision
Our architecture is structured to streamline testing and future updates, enhancing maintainability and traceability. Our design is informed by ISO 14971 guidelines to identify and mitigate risks by design. Each module and data flow prioritizes safety, reliability, and regulatory compliance.
Structured Architectural Design: Building a Robust, Scalable Software Architecture
Our coding standards include robust risk controls, particularly for safety-critical functions, to meet IEC 62304 requirements and deliver consistent performance. We implement peer-to-peer code reviews to maintain high-quality, error-free code, allowing each developer to assess and optimize their peers' work.
Rigorous Implementation with Code Quality Checks
Tech Exactly actively applies ISO 14971 guidelines to perform hazard analysis, assessing potential risks at each development stage.: We maintain a comprehensive risk management file to document identified risks, mitigations, and safety controls for each phase of development.
Comprehensive Risk Management Aligned with ISO 14971
We conduct unit, integration, and system testing to verify that every component and function operates as intended and integrates seamlessly. We leverage IEC 62366 guidelines to ensure a user-friendly interface and intuitive instructions for use, optimizing both the user experience and patient safety.
Thorough Verification & Validation (V&V) for Quality Assurance
We monitor all software versions and document changes, ensuring full traceability and consistent performance across updates. Every modification is carefully logged, reviewed, and tracked to prevent unauthorized changes and maintain the software’s integrity.
Meticulous Configuration Management for Consistency
Proactive Monitoring and Maintenance: Post-launch, we provide ongoing support, tracking performance, addressing issues, and keeping the software compliant and up-to-date. As regulations and technology evolve, we’re here to help you keep pace, ensuring your software is always ready for future advancements.
Post-Release Support & Problem Resolution: Your Partner Beyond Launch
Every project begins with creating a classification matrix that identifies acceptable risks and classifies software safety under IEC 62304 guidelines. By categorizing your software as Class A, B, or C, we align design, testing, and verification requirements to the necessary safety standards.
Software Safety Classification: Laying a Compliance-Driven Foundation
Requirements capture functional, safety, and user needs to define clear, traceable expectations that inform design and implementation.
Requirements Analysis: Documenting Needs with Clarity and Precision
Our architecture is structured to streamline testing and future updates, enhancing maintainability and traceability. Our design is informed by ISO 14971 guidelines to identify and mitigate risks by design. Each module and data flow prioritizes safety, reliability, and regulatory compliance.
Structured Architectural Design: Building a Robust, Scalable Software Architecture
Our coding standards include robust risk controls, particularly for safety-critical functions, to meet IEC 62304 requirements and deliver consistent performance. We implement peer-to-peer code reviews to maintain high-quality, error-free code, allowing each developer to assess and optimize their peers' work.
Rigorous Implementation with Code Quality Checks
Tech Exactly actively applies ISO 14971 guidelines to perform hazard analysis, assessing potential risks at each development stage.: We maintain a comprehensive risk management file to document identified risks, mitigations, and safety controls for each phase of development.
Comprehensive Risk Management Aligned with ISO 14971
We conduct unit, integration, and system testing to verify that every component and function operates as intended and integrates seamlessly. We leverage IEC 62366 guidelines to ensure a user-friendly interface and intuitive instructions for use, optimizing both the user experience and patient safety.
Thorough Verification & Validation (V&V) for Quality Assurance
We monitor all software versions and document changes, ensuring full traceability and consistent performance across updates. Every modification is carefully logged, reviewed, and tracked to prevent unauthorized changes and maintain the software’s integrity.
Meticulous Configuration Management for Consistency
Proactive Monitoring and Maintenance: Post-launch, we provide ongoing support, tracking performance, addressing issues, and keeping the software compliant and up-to-date. As regulations and technology evolve, we’re here to help you keep pace, ensuring your software is always ready for future advancements.
Post-Release Support & Problem Resolution: Your Partner Beyond Launch
Take a look at our Case Studies
We are proud of what we have built. Let us walk you through our projects.
IEC 62304-Compliant Mobile App Mobile App for Accurate Test Interpretation
FAQ
- Requirement analysis and system design.
- Software coding, testing, and validation.
- Compliance with FDA, CE, or ISO 13485 standards.
- Risk assessment, documentation, hardware integration, and post-launch maintenance.
- Ensures safety, reliability, and effectiveness of medical device software.
- Ensure devices meet strict safety and regulatory standards.
- Provide reliable functionality and seamless integration with existing systems.
- Offer end-to-end solutions: concept, prototyping, testing, certification, deployment.
- Reduce development risks, accelerate time-to-market, and deliver high-quality devices.
- Developed following strict regulatory frameworks (FDA, CE, ISO 13485).
- Includes thorough requirement analysis, risk assessment, and safety planning.
- Software undergoes rigorous testing, validation, and verification.
- Documentation is maintained for compliance audits and certification.
- Ensures devices are safe, reliable, and effective for clinical use.
- Embedded systems for diagnostic and therapeutic devices.
- Patient monitoring software and wearable health applications.
- Imaging and data analysis software for clinical diagnostics.
- Connected IoT healthcare solutions for real-time monitoring and remote care.
- Enable faster clinical decision-making, improve operational efficiency, and enhance patient safety.
Ready to Develop a Compliant, High-Quality Medical Device Solution?
Let’s discuss how we can turn your vision into a secure, IEC 62304-compliant solution that transforms patient care.