20+
years of experience in software development
300+
successful projects completed
7%
turnover
rate
200+
experienced developers
70%
of senior
experts
85%
customers entrust us with new projects
Why medical device software development with NEKLO
Medical devices software development: Core services
AI development for medical devices
Software in Medical Devices (SiMD)
Software as a Medical Device (SaMD)
Internet of Medical Things (IoMT)
Clinical information systems
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Medical device app development
Patient engagement apps
Enable patients to be more informed and in touch with the clinicians via software without offline hurdles in healthcare institutions, so that all sides benefit from convenient telemedicine solutions.
Diagnostic support apps
Make the diagnosis more accurate with medical software that analyzes symptoms, clinical images, and lab data.
Remote patient monitoring (RPM) apps
Allow for swift data transfer from patient’s wearables or home devices to healthcare providers, supporting early interventions without in-person visits.
Surgical assistance apps
Equip surgeons with real-time data, navigation, and robotic device control, whether for minimally invasive or complex surgical procedures.
Medical imaging and visualization apps
Choose top-notch solutions in medical imaging and visualization and make healthcare diagnostics as precise and shareable as health providers could ever imagine.
Rehabilitation and physical therapy apps
Software with built-in motion sensors and remote guidance such as real-time feedback and virtual physiotherapy sessions, are effective for post-surgery or post-injury patients.
Flawless medical devices software development
Need a software vendor with a proven record of successful projects? Look no further than NEKLO!
Technologies
Front-end
HTML 5
CSS3
JavaScript
MatLab
React
Vue.js
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Angular
Mobx
Back-end
ASP.NET Core
C#
Django
Ruby on Rails
Embedded C
_Java.svg)
Java
Node.js
_.NET.svg)
.NET
PHP
Python
_Ruby.svg)
Ruby
DevOps
Docker
Prometheus
GitLab CI/CD
CircleCI
_AWS.svg)
AWS
_Google%20Cloud.svg)
Google Cloud
_Kubernetes.svg)
Kubernetes
Terraform
Jenkins
Ansible
Azure
Grafana
ELK
Device connectivity
Wi-Fi
5G
Bluetooth
NFC
Zigbee
LoRa
Data storages
SQL
MySQL
Oracle
PostgreSQL
How we do medical device software design
1. Requirements gathering
We start by diving deep into your product vision, technical goals, and user needs, coming from healthcare providers, patients, or other stakeholders. Based on these requirements, we help choose the right model for medical devices development and clearly outline timelines, deliverables, and budgets.
2. Risk analysis
Before any code is written, we do early mitigation planning to assess hazards, such as system malfunctions, data breaches, or unauthorized access. We map these risks to international and country-specific standards like ISO 14971 and IEC 62304. From day one, we also consider key compliance requirements, such as HIPAA, GDPR, and FDA/MDR.
3. Design and prototyping
We create a prototype of your healthcare product with the principles of user-centered design in mind. You can test your assumptions and interface usability early and collect actionable feedback from the end users, with all bases covered before the software development stage.
4. Development and testing phase
We implement code and UI/UX design, aligning them with healthcare standards to ensure hassle-free certification for your product. If needed, we take care of integrations, like embedding AI tools into current workflows or connection to EHR platforms. Our QA engineers test functionality and security rigorously throughout the process.
5. Regulatory compliance
We help you come prepared for the regulatory approval process. Stay assured you have full technical documentation required for submission, including risk assessments, software architecture, testing reports, and traceability matrices. Supporting Class I, II, or III healthcare device classifications is also our scope of work.
6. Integration with smart devices
Whether your solution needs to connect with wearable health monitors, implantable or general-purpose consumer devices, we ensure it has secure communication, accurate data synchronization and impeccable performance.
7. Maintenance and updates
We don’t just build and deliver — we stick with you for the long haul. Ongoing maintenance, patches, security and compliance updates is what we offer our clients.
1. Requirements gathering
We start by diving deep into your product vision, technical goals, and user needs, coming from healthcare providers, patients, or other stakeholders. Based on these requirements, we help choose the right model for medical devices development and clearly outline timelines, deliverables, and budgets.
2. Risk analysis
Before any code is written, we do early mitigation planning to assess hazards, such as system malfunctions, data breaches, or unauthorized access. We map these risks to international and country-specific standards like ISO 14971 and IEC 62304. From day one, we also consider key compliance requirements, such as HIPAA, GDPR, and FDA/MDR.
3. Design and prototyping
We create a prototype of your healthcare product with the principles of user-centered design in mind. You can test your assumptions and interface usability early and collect actionable feedback from the end users, with all bases covered before the software development stage.
4. Development and testing phase
We implement code and UI/UX design, aligning them with healthcare standards to ensure hassle-free certification for your product. If needed, we take care of integrations, like embedding AI tools into current workflows or connection to EHR platforms. Our QA engineers test functionality and security rigorously throughout the process.
5. Regulatory compliance
We help you come prepared for the regulatory approval process. Stay assured you have full technical documentation required for submission, including risk assessments, software architecture, testing reports, and traceability matrices. Supporting Class I, II, or III healthcare device classifications is also our scope of work.
6. Integration with smart devices
Whether your solution needs to connect with wearable health monitors, implantable or general-purpose consumer devices, we ensure it has secure communication, accurate data synchronization and impeccable performance.
7. Maintenance and updates
We don’t just build and deliver — we stick with you for the long haul. Ongoing maintenance, patches, security and compliance updates is what we offer our clients.
Collaboration models we offer
Dedicated team
Hire a skilled development team that will devote all their energy and skills to your project, with consistent results within time and budget.
FAQ
What types of medical device software do you develop?
Do you follow IEC 62304 and FDA/MDR regulations?
Can you help with software validation and documentation for audits?
Can you integrate medical device software with EHR or mobile apps?
How do you ensure secure data transmission from medical devices?
Do you support OTA updates and firmware delivery?
Can you help classify software under FDA or MDR frameworks?
Do you build software that interacts with hardware sensors?
Can you support us beyond development — e.g. testing or post-market updates?
What makes NEKLO a strong partner for medical device software?
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