Work with an ISO 13485 certified software development company that really cares

If what you care about the most are the people you’re building your product for and the ones you’re building it with, we’re quite sure we’ll get along. And if you work in healthcare, our interests align even more. We get what it means to build digital health applications and we have experience working with various clients in this field. Whatever your needs in the area of software for healthcare are, there’s a lot we can help you with.

Passion for healthcare runs in our veins

We added the word “Healthcare” to our company’s name in 2020. This change reflects what kinds of projects we decided to focus on – ones that have a positive impact on people’s lives. We made that decision much earlier, though. Actually, all of Revolve Healthcare’s founders and many employees have some kind of a background in medicine, psychology, biomedical engineering, and other areas related to healthcare.

If you work in healthcare too, you won’t be surprised when we say that our company’s mission attracts some of the greatest IT (and not only) specialists. Our people want to do something meaningful and be part of the change they’d like to see in the world – while working with new technologies and innovations.

A technical project meeting of four people by a big wooden table in front of a TV screen

Beyond software development

We always put emphasis on quality and documenting our work and processes well. But we understand that developing medical software means taking things to a whole other level. It’s not just about building a product that perfectly answers your users’ needs and is beautiful, scalable, and unique.

There are also specific standards and regulations that your software development partner needs to follow and comply with. As an ISO 13485 certified company that works with medical companies on a daily basis, we know and understand all that.

Whether you run a startup or an established business and whether you’re just starting or have a lot of experience in the industry – we’ve got you covered.

Here are a few things we can do for you on top of software development services:

help you understand the entire MDR certification process and define what class your software fits into – and if it should be a medical device (SaMD) at all

set up a meeting – or a series of meetings – with our Head Of Regulatory Affairs to consult your specific challenges

organise the entire process of software development (including digital product design, UX/UI, quality assurance, risk management, documentation, and reporting) for you

assist you in conducting a risk analysis of software as a medical device, in particular taking into account the technological risks

create a roadmap for your digital product certification

audit your existing software and documentation

help you with your quality management system (QMS)

prepare documentation that makes your certification process smoother

Why outsourcing your medical software development to us makes sense

Outsourcing isn’t for everyone. You can read about its ups and downs on our blog. But when it comes to medical software development, it simply may be the fastest and safest option for you – as long as you choose the right partner.

We’re an ISO 13485 certified company

This means we can become your critical supplier and a partner in the software certification process. The ISO certificate is also a stamp of quality and accuracy of our processes. There’s no need to educate our people on what software development in healthcare should look like or how to document it – they already know all that.

We create a lot of technical documentation for you

The more of the process we’re responsible for, from design to implementation, the more documents required for certification we can prepare for you or with you (see more below).

We follow agile software development methodologies, while meeting the IEC 62366 and IEC 62304 standards

IEC 62366 stands for usability engineering and IEC 62304 for software life cycle processes. Thus, we can take care of the entire design and development process for you. And we’ll do it in a certifiable manner.

We know how to work with the HL7 FHIR standard for healthcare information exchange

The Fast Healthcare Interoperability Resources (HL7 FHIR) standard describes how healthcare information can be exchanged between different computer systems. And if you‘re building software for healthcare, it’s good to be aware of where and how to use it. You don’t have to understand the technicalities of it though – if you let us take care of it for you.

You get a dedicated team of design and development specialists led by an experienced project leader

Additionally, the people handling your project are always backed by the cumulative know-how of everyone in our company. This means you can focus on other important matters and trust us with your software.

Our people are great to work with and speak good English

You don’t have to worry about communication issues. We’re a people-first company that’s more about openness and taking ownership than control and order-giving. This is what really enables us to deliver quality software that improves and saves human lives. And all of our employees are simply great people.

Properly documented processes for easier certification

As you know, there’s a whole lot of documentation you need to produce in order to get your app certified as a medical device. We get it, we’ve been through our own certification, and we work with clients who have gone through MDR certification or are getting ready to do so. Thanks to which, we can make your life easier.

We can help you with up to:

0%

90%

of the project design and manufacturing information

0%

70%

of the benefit-risk analysis and risk management

0%

60%

of the product verification and validation

0%

50%

of the device description and specification

0%

50%

of the information to be supplied by the manufacturer

0%

50%

of the technical documentation on post-market surveillance

How we can help with your healthcare app development and certification journey

End-to-end software development is our specialty. That means we’re more than happy to take care of the entire process for you, from idea to implementation. But if you only need to consult something or supplement your existing team with engineers experienced in healthcare application development, you can count on us too.

Here you can see some of the things we can help you with. But, feel free to schedule a call with us, even if your medical software needs don’t seem to fit in any of that. We’re always excited to get to know new companies who innovate in the medtech space.

end-to-end software design & development (covering IEC 62366 and IEC 62304)

team augmentation

discovery workshops

consultations with our Head Of Regulatory Affairs

MDR and DiGA compliance consultations

usability consultations (incl. IEC 62366)

technical consultations (incl. agile IEC 62304)

specialist audits – technological readiness, documentation, UX, and more

Let’s talk about your digital health project

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