With 250+ MedTech engineers and compliance specialists, Andersen offers the expertise to navigate complex medical device regulations across global markets.
Medical device software development services
As a full-cycle medical device software development services provider, Andersen helps players in the medical device industry build compliant, safety-critical solutions that ensure regulatory compliance, drive better patient outcomes, and accelerate time-to-market while reducing risks.
Build your medical device software with Andersen
With 19 years of experience, Andersen has refined its software development process to deliver compliant medical software that meets FDA and EU MDR requirements.
With 230+ healthcare clients worldwide, Andersen builds secure software that protects patient data and integrates seamlessly with existing systems.
Our medical device software development services
We provide end-to-end medical device software development services tailored to your product vision, regulatory roadmap, and market access strategy.
Medical software strategy consulting
We assess your clinical workflows and product vision to build a clear strategic roadmap that aligns your software initiatives with business goals and key regulatory milestones.
Medical device regulatory compliance consulting
Our experts interpret FDA, EU MDR, and other global frameworks to embed compliance into every stage of your medical device software development, reducing submission risks.
Software as a Medical Device (SaMD)
We design, develop, and validate Software as a Medical Device products that function independently from hardware, applying medical device software development standards.
Embedded Systems Development
We engineer reliable embedded software for medical equipment, integrating hardware and software layers with precision to support real-time critical functions.
System Integration & Interoperability
We connect your medical device software with hospital networks, EMR systems, and third-party platforms to enable seamless data exchange across care settings.
Post-Launch Maintenance & Support
We provide ongoing support, security patches, and feature updates to keep your medical device software compliant, secure, and performant throughout its lifecycle.
Healthcare organizations we serve
We deliver tailored medical device software development solutions that address the unique operational, clinical, and regulatory challenges faced by different healthcare providers.
For hospitals and clinics, we develop medical device software that enhances clinical decision-making, streamlines workflows, and ensures seamless integration with existing hospital infrastructure to improve patient care delivery.
- Integrate device software with EMR systems and clinical workflows;
- Enable real-time patient monitoring and data visualization;
- Ensure compliance with hospital-grade security and interoperability standards;
- Reduce manual documentation through automated data capture.
For diagnostic and R&D laboratories, we engineer medical device software that automates complex analytical processes, manages high-volume testing data, and maintains traceability required for regulatory submissions and quality control.
- Automate data collection and analysis from diagnostic devices;
- Ensure traceability and audit trails for regulatory compliance;
- Integrate with laboratory information management systems (LIMS);
- Support high-throughput testing environments with reliable performance.
For pharmaceutical companies, we build medical device software that supports clinical trial operations, drug delivery systems, and pharmacovigilance, ensuring data integrity and regulatory alignment from development through post-market surveillance — all designed specifically for medical purposes.
- Support drug delivery device software and companion diagnostics;
- Enable secure clinical trial data collection and management;
- Ensure compliance with GxP and FDA validation requirements;
- Facilitate pharmacovigilance reporting and adverse event tracking.
For clinical research organizations, we deliver medical device software that streamlines trial management and monitoring, helping CROs accelerate timelines while maintaining data quality.
- Enable electronic data capture and remote monitoring capabilities;
- Support multi-site trial coordination and data aggregation;
- Ensure compliance with 21 CFR Part 11 and GDPR;
- Accelerate trial timelines through automated workflows.
For remote patient monitoring providers, we design medical device software that enables continuous data collection, secure transmission, and actionable insights for real-time health monitoring, empowering healthcare teams to deliver proactive care beyond clinical settings.
- Enable real-time health monitoring and alerting systems;
- Ensure secure data transmission and HIPAA compliance;
- Integrate with telehealth platforms and clinical dashboards;
- Support scalable device connectivity and data aggregation.
For medical device manufacturers, we deliver full-cycle medical device software development that covers everything from embedded software to cloud connectivity, ensuring regulatory readiness and seamless integration with hardware components.
- Develop embedded software for implantable and diagnostic devices;
- Ensure FDA, EU MDR, and IEC 62304 compliance;
- Enable secure wireless connectivity and cloud integration;
- Provide post-launch maintenance and software update capabilities.
For health tech startups, we offer agile development for medical device software that balances speed-to-market with regulatory compliance, helping startups validate their solutions quickly while building scalable, investor-ready products.
- Accelerate MVP development with agile methodology;
- Design for regulatory readiness from day one;
- Build scalable architectures for future growth;
- Support prototyping, validation, and regulatory submissions.
Why Andersen as your medical device software development company
As a medical device software development company, Andersen delivers compliant, scalable solutions that integrate risk management into every phase, reducing time-to-market and regulatory risks while improving outcomes for healthcare organizations.
Certified team powering your MedTech product
Our certified engineers combine technical excellence with expertise in regulatory bodies' requirements to deliver medical device software development that meets global compliance requirements.
Medical device software solutions we develop
We engineer medical device software across clinical, home, and wearable settings, delivering reliable, compliant solutions for diverse care environments.
In-Hospital Device Software
We build reliable software for medical equipment used in clinical environments.
Infusion pumps and patient monitoring systems;
Ventilators and anesthesia delivery systems;
Diagnostic imaging and PACS workstations;
Surgical navigation and robotic systems.
In-Home Device Software
We create intuitive software for home-use medical devices that empowers patients.
Connected blood glucose meters and insulin pumps;
Oxygen concentrators and CPAP machines;
Remote patient monitoring kits and vital sign trackers;
Medication adherence and smart pill dispensers.
On-Body Device Software
We develop secure software for wearable devices with real-time health monitoring.
Continuous glucose monitors (CGMs);
Wearable cardiac monitors and event recorders;
Drug delivery patches and smart sensors;
Activity trackers with clinical-grade accuracy.
Our medical device software development case studies
We deliver medical device software development projects that solve real clinical and operational challenges, from patient monitoring to diagnostic imaging.
Finland
IoT-based health tracking solution
Andersen built an IoT health tracking solution that collects vital data, analyzes sleep statistics, and notifies clinicians in an emergency. The system processes data from 12,000 devices simultaneously, increasing accuracy by 20% and enabling remote patient monitoring for elderly care.
Medical device software use cases
We apply medical device software development expertise across key clinical scenarios, delivering solutions that improve care delivery, operational efficiency, and patient safety.
Remote Patient Care
We develop software that enables continuous monitoring of patients outside clinical settings, transmitting vital signs and health data to healthcare providers for timely intervention and chronic disease management, improving patient outcomes.
Patient Self-Service Portals
We build portals that give patients secure access to their health data, appointment scheduling, and direct communication with providers, empowering them to take an active role in their care.
Diagnostic Support
We create software that assists healthcare professionals in interpreting medical images, lab results, and patient histories, enabling faster, more accurate diagnoses through advanced analytics and decision support tools.
Clinical Data Analysis
We develop platforms that aggregate and analyze clinical data from multiple sources, uncovering patterns and insights that support evidence-based treatment plans and population health management.
Clinical Facility Operations & Monitoring
We build software that optimizes hospital workflows, tracks equipment utilization, and monitors facility performance, helping healthcare organizations improve resource allocation and operational efficiency.
Medication Administration
We design software that automates medication ordering, verification, and administration tracking, reducing errors and ensuring patients receive the right dose at the right time, enhancing overall patient care.
Testimonials
Our clients across the healthcare industry trust our medical device software development expertise to deliver compliant, innovative solutions that improve patient care and operational efficiency.
Integration capabilities
We deliver seamless medical device software development integrations that connect your device software with healthcare organizations, enabling secure data exchange, workflow automation, and better clinical decisions.
We integrate medical device software with EMR and EHR systems, ensuring that patient data from diagnostic devices, monitoring equipment, and wearables flows directly into electronic health records.
- Automate data transfer from devices to patient records;
- Enable real-time updates for clinical decision support;
- Ensure compliance with HIPAA and data privacy standards;
- Support interoperability with major EMR/EHR vendors.
We connect medical devices with hospital management systems, enabling seamless integration between clinical equipment and administrative workflows. This improves resource allocation, streamlines patient admissions, and enhances operational visibility across departments.
- Automate patient data capture during admissions and procedures;
- Integrate device usage data for billing and inventory management;
- Enable real-time tracking of equipment status and location;
- Support reporting for operational efficiency and compliance.
We integrate medication delivery devices and infusion pumps with pharmacy management systems, ensuring accurate ordering, verification, and administration tracking. This reduces medication errors and improves patient safety across inpatient and outpatient settings.
- Automate medication orders and electronic prescribing;
- Enable real-time verification of dosages and drug interactions;
- Track administration records and maintain audit trails;
- Support integration with automated dispensing cabinets.
We connect medical devices with telehealth platforms, enabling remote patient monitoring, virtual consultations, and secure data sharing. This empowers healthcare providers to deliver timely care to patients in home settings while maintaining continuity.
- Transmit vital signs and device data during virtual visits;
- Enable secure video consultations and patient messaging;
- Support remote monitoring of chronic conditions;
- Ensure HIPAA-compliant data transmission and storage.
We integrate imaging devices and diagnostic software with PACS and DICOM systems, enabling seamless storage, retrieval, and sharing of medical images. This streamlines radiology workflows, improves diagnostic accuracy, and supports collaboration across care teams.
- Automate DICOM image capture and secure storage;
- Enable fast image retrieval and sharing across departments;
- Integrate with diagnostic AI and decision support tools;
- Ensure compliance with imaging standards and data privacy.
Partner with us to connect your medical devices with the systems that drive modern healthcare.
Advanced tech stack for medical devices software development
Artificial Intelligence
We embed artificial intelligence into medical device software to enable real-time decision support, image recognition, and predictive data analytics. This transforms raw clinical data into actionable insights, improving diagnostic accuracy, automating routine tasks, and delivering better clinical outcomes across diverse environments.
Machine Learning
We apply machine learning algorithms to medical device data, enabling pattern recognition, anomaly detection, and continuous model improvement. This empowers devices to learn from clinical data and deliver increasingly accurate predictions and recommendations.
Data Science
We use data science to extract meaningful insights from complex medical device data, enabling population health analysis, treatment optimization, and clinical research. This supports evidence-based decision-making and improves care delivery across healthcare systems.
Blockchain
We leverage blockchain to ensure secure, tamper-proof storage and sharing of medical device data, enabling transparent audit trails and patient-controlled access. This enhances trust, security, and compliance in connected healthcare ecosystems.
Computer Vision
We integrate computer vision into medical devices to enable automated image analysis, object detection, and real-time visual diagnostics. This supports clinicians in interpreting medical images with greater speed and accuracy, improving diagnostic workflows.
Proven medical device software development process
Our proven process combines regulatory rigor with engineering excellence, delivering compliant, reliable solutions that accelerate time-to-market and reduce project management risks.
We conduct thorough software requirements analysis to capture clinical needs, regulatory mandates, and user expectations. This ensures your medical device software is built on a solid foundation that aligns with business goals and compliance requirements.
Insights and best practices for medical device software development
We share expert articles to help organizations navigate regulatory complexity, adopt advanced technologies, and deliver safer device software.
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FAQ
We follow FDA guidance and IEC 62304 standards, embedding compliance into every development phase. Our approach includes:
- Documented software development process for all medical device software projects, including class III devices and new software development with end to end development coverage;
- Traceability from requirements to testing, including all software components;
- Validation and verification at each stage, including embedded medical software and signal processing algorithms, ensuring seamless interaction with hardware medical devices;
- Usability testing and user interfaces validation to meet human factors requirements;
- Regular audits and readiness for FDA submissions with detailed documentation.
Order a free IT consultation
What happens next?
An expert contacts you after having analyzed your requirements;
If needed, we sign an NDA to ensure the highest privacy level;
We submit a comprehensive project proposal with estimates, timelines, CVs, etc.
Customers who trust us
