Medical Software Development

We can help you turn your concept for medical software into an effective development plan. How? First, we conduct in-depth research on your users’ needs, problems, habits, and more. Next, during workshops, we get to know your business, ideas, values, and work done so far. Through these meetings, we can ideate the User Experience, compose a work timeframe and assess your project's technical feasibility.

Then, we prepare the information architecture, clickable prototypes, or other mockups adapted to your project. As a result, you will get a documented vision of your product which can be used during software development. Last, we will test the prototype among the users. The process can take 2 to 6 weeks and will get you closer to successfully creating your medical software. 

Medical software development can be a demanding task if done on your own. At Revolve, we have a team of experienced Software Developers, Quality Assurance Specialists, Regulatory Affairs Experts, Business Analytics, and Project Leaders who can guide you through every step of the process.

We are an ISO 13485 certified company, so you can be sure our development process complies with this standard. What’s more, we provide you with the high level of cybersecurity and data protection as we comply with GDPR and HIPAA, as well as follow OWASP and ISO 27001 recommendations. We guarantee that as your critical supplier, we will safely and responsibly develop your SaMD, taking the stress off your shoulders.

ISO 13485 sets the rules for creating quality management systems when developing medical devices. The crucial aspect of this standard is that every step of the development process should be traceable.

We understand that manufacturers and critical suppliers are obliged to comply with ISO 13485. Thus, Revolve is certified with ISO 13485, which guarantees that the procedures implemented within our organisation will facilitate the development of SaMD. What’s more, we create transparent documentation from the very beginning of the project.

You can read more about ISO 13485 on our blog.

IEC 62304 is the standard containing the rules for developing and maintaining medical software. The point of this is to reduce potential risks that could threaten the user's well-being.

Why should you be interested in this standard? Not only to provide the patient with the highest quality software but also as the MDR demands it. When developing medical software at Revolve, we comply with IEC 62304.

You will find more information on IEC 62304 in our blog article.

IEC 62366 is a standard that includes the rules for specifying, developing, and using a medical device in terms of safety. It demands that the manufacturer establish and maintain risks related to the patient's app usage.

This standard is essential for every manufacturer to follow. Thanks to this, your app is safer for the users. Revolve always complies with the IEC 62366 when developing medical software. 

HL7 FHIR (Health Level Seven International, Fast Healthcare Interoperability Resources) is a framework that aims for interoperability in terms of easy patient data exchange. This framework allows easy adaptation of its resources to your medical software app.

As Revolve Healthcare, we are a member of HL7 International; thus, we aim to ensure that our medical software fulfils the interoperability function.

Find more information on HL7 FHIR in our article.

HL7 CDA (Health Level Seven International, Clinical Data Architecture) is an XML standard that specifies the structure of medical records, such as documents detailing a patient's treatment. Thanks to this framework, processing clinical data becomes easier for both healthcare providers and machines.

When developing your medical software, we follow the CDA standard to provide comprehensive and high-quality clinical data exchange.