Medical Software Development

Benefits of working with us

Do you struggle with medical software development?

We know how challenging it can be to bring your idea for SaMD (Software as a Medical Device) to life.

It requires many skills, resources, and preparing a step-by-step work plan for the development and certification process according to the EU regulations. We can support you through every task, answer your questions, and dispel any doubts.

What do you get when working with us?

Reliable, time-efficient, and original methodology

We developed a process blending modern agile approaches (Scrum, Scrumban) with IEC 62304, IEC 82304, IEC 14871, and other regulations

A team of experts in healthcare

Our knowledgeable team will plan the work, advise during the process and take the development weight off your shoulders

Services tailored to your needs

We adjust our Regulatory Consultations, Product Design and Software Development services depending on where are you at

No distress about compliance

We know how to work with all industry standards: ISO 13485, IEC 62304, IEC 62366, HL7 CDA/FHIR, etc.

Transparent processes

You have the full control over the scope, budget and progress

Cybersecurity and data privacy

We maintain cybersecurity in accordance with OWASP recommendations and data privacy compliant with GDPR/HIPAA

How Revolve can help you with medical software development?

So, are you planning on getting assistance on your SaMD from ideation to CE certification? Or maybe you only need advice on some aspects of the process? Pick what you need:

Regulatory Consultations
Product Design
Software Development

Not sure about the type of service you need?

Our services are complex and can be modified up to your wishes. Contact us, and let’s talk about your needs in the medical software development process.

How do we do it at Revolve Healthcare?

We carry out projects using our established process that mixes Scrum with IEC 62366, IEC 62304, IEC 82304, and IEC 14971, making the development process for medical software safer, easier, and faster.

We include routine risk analysis during every sprint without slowing down our job. We trace, control, and test every SOUP and every line of code. Preparation of transparent documentation is divided among team members, making it more time-efficient and Quality Assurance Specialists ensure that everything is done correctly.

This way you get the time to focus on what matters the most – your patients.

Medical software projects we’ve worked on

See the companies that trusted us.

Contact Form

Let’s talk about your medical software!

Schedule a Discovery Meeting with us.

It’s a free video call with one of our Partnership Managers, Tech Expert, and Regulatory Expert when necessary
It lasts for about 45 minutes
During the call, you can ask any questions on medical software development, MDR requirements, or writing down intended use
The call doesn’t oblige you to longer cooperation
This meeting is an opportunity to obtain high-level information on medical software development in compliance with MDR

What you should know about standards and requirements for medical software

Developing reliable and safe medical software demands compliance with some international regulations. When we work on medical devices, we always consider compliance with the following standards.

Medical Device Regulation
ISO 13485 – quality management system
IEC 62304 – medical software life cycle
IEC 62366 – usability engineering of medical device
HL7 FHIR – interoperability standards
HL7 CDA – structure of electronic medical records

We are ISO 13485 certified

We are ISO 13485 certified for the software design and development services for the medical devices industry, so we maintain a high-quality management system when working on our clients' apps.

Revolve Healthcare always develops medical software in compliance with standards like IEC 62304 and IEC 62366. Also, we are an HL7 International member and actively contribute to global healthcare interoperability standards. We aim for excellence; thus, we are currently implementing ISO 27001 in our company.

At Revolve, we make sure that your medical software complies with all the necessary medical standards during every step of the development process.

Our Experts

custom-biotech-software-development-lukasz-bandala-revolve-healthcare

Łukasz Bandała

CTO & co-CEO of Revolve Healthcare. MSc in Computer Science in Control and Management and BSc in Biomedical Engineering. Expert in technical supervision of quality management processes in medical software development projects.

custom-biotech-software-development-malgorzata-gonsior-kustosz-revolve-healthcare

Małgorzata Gonsior-Kustosz, PhD

Head of Regulatory Affairs and an expert in innovative medical technologies with a background in medical physics, and as a manager of over 30 R&D projects in MedTech. In the medical devices industry since 2007. Her PhD focused on Materials Engineering.

Jakub Rawicki

Delivery Manager & Project Leader, former CTO of interactive mirror manufacturer Abyss Glass. Experienced in leading IT teams using agile methodologies. Responsible for ensuring quality of the medical software projects carried out.

Karol Kaprusiak

Co-CEO of Revolve Healthcare & Head of Operations. A psychologist with over 10 years of experience in running businesses in the fields of marketing and technology. Delivered several dozen projects for the clients in Europe.

Do you have more questions on medical software development?

We can discuss them during the Discovery Meeting:

How can we help you bring your idea to life
What are common medical software development challenges
How our team works on medical software development
How do we maintain compliance with international standards

Fill in the form to book a discovery meeting and get a face to face explanation of the topics above.

Want to learn more about medical software development on your own?

Check out our articles on medical software development.

FAQ

Is my software medical or healthcare software?

Medical software is software which can be used for diagnosing, treating, and alleviating disease. Thus, medical software can be prescribed by a healthcare practitioner and used in addition to traditional treatment or as a replacement of conventional medicine (such as pills). If your software is supposed to help people with medical conditions, it might be medical software.

On the other hand, healthcare software isn’t suitable for helping in disease. Its role is to help maintain a healthy lifestyle, for example by tracking daily steps. What’s more, you don’t need a prescription from a doctor to use this kind of app.

At Revolve we also help with developing healthcare software, so feel free to contact us.

Do I have to CE mark my medical software?

You need a CE mark if you want to sell your app as medical software in the European Union. Some questions might aid you in establishing if you need to go through the process. You can find a helpful flowchart here.

How long is the medical software development process?

It’s hard to answer this question as it depends on the complexity of the software and the activities needed to undertake during the certification process. It can take up to 2-3 years. You can read more about this in our article.

How much does medical software development cost?

It depends on the length of medical software development, amount of people included in the process, and the complexity of the certification process. We describe all those variables in our article.

Do you help to develop medical software for FDA standards?

We primarily focus on introducing medical software to the European market; however, we can also help you develop medical software up to FDA standards.

Do you help with medical software development in compliance with DiGAV?

Yes, we can help you with developing medical software in compliance with DiGAV. You can read the interview with the ABAStroke representative who has successfully introduced their app to the German market.