We specialize in medical devices development backed by GDPR & HIPAA compliance as well as Amazon Web Services and Microsoft Azure certifications. Empeek team serves numerous healthcare providers via medical device software development for both small IoT wearables and sophisticated large clinical devices.
The complexity of the specific software for medical devices grows with the increasing market globalization. It creates new regulatory obligations, and an environment that values safety, quality, and reliability. We build solutions for various medical devices that enable the hospitals to cut unnecessary costs, reduce time-to-market, and enhance the treatment quality.
To achieve significant time savings, we create solutions capable of:
• identifying each asset and document
• data storage with appropriate version controls
• automated changes for all documents
• displaying dozens vital signs data in real-time
• visualizing data analytics
Overcoming the Digital-Era Challenges
Managing Massive Volumes of Data
Many healthcare entities find it hard to maintain a vast amount of documentation, while their back-offices are often overloaded with routine work. A significant amount of records and documentation are required not only by regulator but also by manufacturers. This data is commonly maintained by Excel tables and Google Drive folders, making it difficult to sync. We help companies to consolidate their data storage and make the audit process more manageable.
Not only data storage but also the traceability and identification of relationships between documents is important. To ensure the code, requirement, and design specification are connected and traceable, many entities choose to manage it manually. This approach drains money and time. Empeek advocates the consistent approach by labeling every bit of data with a system-generated unique identifier. It makes automated trace reporting possible and helps to highlight the risky areas.
Cost-Effective Document Management
We can’t avoid changes, but we can make them easier to implement. In a highly regulated environment, you need to consider every change and make sure it is documented correctly. Modern tracking practices often lack consistency and unified storage. We offer a cost-effective change management platform that automates the change control and simplifies your workflow.
Automated Risks Handling
While found in the early development stage, product defects are less expensive to fix. For medical devices, a product recall can affect not only your efficiency but also your brand reputation. To mitigate these risks, companies must automate trackings. You can achieve it by adopting the automated failure model and digitalizing your change management strategy.
Stages of Medical Devices Software Development
To launch the medical device development process, we need to identify the requirements, provide risk analysis, quote approvals, and start the first sprint. Once we gather all your business-specific requirements, we can start moving toward your business challenges.
Keeping in mind your performance requirements, we build the UI/UX prototypes and make the design architecture of your medical devices’ software. We also set up the continuous integration server and include all the security aspects into the big picture of the future product.
At this stage, we start coding in accordance with the latest Agile or Scrum practices. Following the technology, regulatory, and security standards, we start the development process with regular code reviews and repository storage.
Testing & Integration
When your future project starts to take a form, Empeek engineers make sure it also works well and passes all the security tests. We use QA automation best practices, such as static analysis, acceptance, performance, usability, and regression testing. On the other hand, we maintain all the documentation while testing and fixing bugs.
Deployment & Maintenance
Here your final stage – deployment – starts. Depending on your business goals, it can be manual, semi-manual, or continuous deployment. We also add new features to your medical devices software to ensure your success. Since it’s a final stage, all the bugs and vulnerabilities are costly to fix. That’s why we advocate the security-first approach from day one of our cooperation. Your medical devices software goes through revision and testing one more time to ensure everything works well.
HIPAA & GDPR Compliance
It is all about security and global standards. No matter if you’re a large hospital entity or a small provider – you deal with the high-risk personal data. To protect every bit of data in your company, we build HIPAA & GDPR compliant medical devices software that handles PHI access correctly.
Modern medical devices become even more connected, and you can’t stop the progress. But you can easily ensure the security of each of your devices by hiring Empeek professionals for FDA-based medical devices software development. We share responsibility for your sensitive data.
Software as a Medical Device Solutions
We make sure your software communicates with your IoMT system, provides robust analytics, and integrates with the current EHR system via HL7/FHIR protocol. Our code tackles treatment management and vital signs monitoring challenges in a timely fashion.
Healthcare IoT Expertise
Empeek gathers Ukraine’s top IT talents into a technological community for outstanding digital health solutions development. We create healthcare IoT monitors, telemedicine apps, clinical data screening software, and home care platforms.
To ensure every bit of personal data is appropriately protected, we build HIPAA and GDPR compliant healthcare IoT solutions. Our team can also re-engineer your current system to gradually become a HIPPA covered entity. Platforms we build support a wide variety of custom message formats, such as EDI, XML, and HL7.
We love .NET technology as it’s a simple but robust system with cross-platform extensions and rapid development. It’s also one of the best ways to build an IoT infrastructure, remote patient monitoring system, or custom IoT extension without additional costs.
Over the 5 years, we developed our customers and partners network around the world. From Israel and Sweden to North America and Australia – every Empeek project is backed by customer success.