With 5 years in IT and 5 years of experience in healthcare software development, backed up by ISO 13485 and IEC 62304 certifications as well as Microsoft Gold Competencies in application development, Qrapp creates highly secure and reliable software for all types of medical devices.
We know the specifics of the three regulatory classes of medical devices and create failure-proof and HIPAA-compliant software for medical equipment safely used by patients as well as all healthcare professionals, including:
When applicable, we make sure our medical software guarantees:
Qrapp offers all-round medical device software development with mature processes that form a seamless workflow in accordance with the stages of a software development life cycle:
We discuss your medical device software concept with you, help you elaborate it and assist with prioritizing requirements.
We transform your requirements into a detailed specification and await your approval before proceeding.
WWe design user-friendly UI for self-explanatory and smooth human-computer interaction.
We implement the functionality of your software in the shortest time possible.
Our quality assurance (QA) processes go in line with the development to ensure high-grade and fully secure medical device software.
We complete the development by successfully installing software on predesignated medical devices.
We provide support services and help your software evolve further for as long as you need it.
At our customer’s request, we also provide the following additional services:
On all stages of medical device software development, we apply OWASP’s S-SDLC (Secure Software Development Life Cycle) practices that involve comprehensive and multi-level quality assurance. We understand that medical device software should be absolutely fault tolerant and therefore must undergo even more rigorous and thorough QA than any other type of software.
As a result of our profound QA processes and practices, we guarantee:
High-quality architecture and code
Flawless user experience
Early prevention and detection of bugs and malfunctions
Medical software product validation according to ISO 13485/IEC 62304
At Qrapp, we believe that architecture defines software reliability, expandability, and security. Our software architectures allow adding new modules and even new types of devices with little to absolutely no rework necessary. We achieve this via ensuring system configurability, clear module interfaces, and good encapsulation in every module.
To meet your individual needs, we offer different cooperation models depending on the business type you have as well as the development methodology and the implementation strategy you prefer.
We welcome all customers and have experience in collaborating with medical device manufacturers, pharmaceutical companies and healthcare software startups.
We apply the development methodology that is beneficial for your project. Regardless of the methodology choice, we guarantee comprehensive and up-to-date documentation, critical for the transparency of the medical software development processes. The methodologies we actively use are:
We're a reliable business partner with mature software development processes that are open to audits. We always keep all our activities highly transparent and let you choose the extent to which you want to be involved in the project. Moreover, you can trust the quality of our account management and the competence of our HR department in selecting the best talent.
Whether you need the full-cycle development of medical device software or professional medical device software development consulting, our experienced team of business analysts, developers and QA specialists is at your service. Feel free to drop us a line and get a quote on your concept or request consulting services for your ongoing development project.