Photo of Małgorzata Gonsior-Kustosz, Head of Regulatory Affairs at Revolve Healthcare.

Authors

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Małgorzata-Gonsior-Kustosz-author-Revolve-Healthcare.webp

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

Build, upgrade, and maintain CE-ready medical device software with an ISO 13485–certified software development company. We deliver compliant, secure, connected solutions aligned with MDR/IVDR, IEC 62304, ISO 14971, cybersecurity and usability requirements.

Medical Device Software Development Services

As a full lifecycle medtech partner and critical supplier under MDR, we develop medical device software that is compliant from the start and prevents costly code rewrites or MDR and IVDR delays. You get embedded, mobile, web, desktop and cloud solutions built right first time with compliance engineered into every stage by our engineering and regulatory teams, ensuring smooth CE approval, reduced audit risk and a product that is safe, connected and ready for the market.

Why medical device companies choose us

<ul><li>Mobile apps for medical devices (including companion apps)</li><li>Connectivity for medical devices</li><li>Software in a medical device (SiMD)</li><li>Firmware development</li><li>Software and documentation transition from MDD to MDR (or IVDR)</li><li>Cost efficient maintenance with remote monitoring</li><li>Post Market Surveillance and CAPA Support</li></ul>We support legal manufacturers across the full software lifecycle. Explore each area to see how we deliver compliant software solutions.

Key areas we support

We deliver end-to-end, certification-ready software and documentation, built from day one to minimise costly rework and avoid certification delays. Our integrated engineering and regulatory approach ensures your project is designed, developed and documented in one compliant flow, with documentation created alongside development rather than after it, across the entire lifecycle from architecture to post market activities.

Our services for medical device software

See how medical device manufacturers use our end to end, compliant software development services in real projects.

Case studies

A regulatory first software development partner for medical devices. Our integrated process supports full design control, verification and traceability expected by legal manufacturers and notified bodies. We operate within an ISO 13485 certified QMS and use our Scrum 62304 framework aligning Agile delivery with IEC 62304, ISO 14971 and IEC 62366. We have contributed to more than ten MDR or IVDR aligned software initiatives ranging from new development to code refactoring and documentation remediation.

About Revolve Healthcare

During the session we can:<ul><li>review your software challenges,</li><li>discuss MDR or IVDR expectations,</li><li>outline the best technical and compliance approach,</li><li>answer questions about documentation.</li></ul>The consultation takes around 45 minutes and does not require any commitment.

Schedule a consultation with our engineering and regulatory specialists

Medical Devices

Do you have an idea for medical software which can change people's lives? Let us help you with its development. At Revolve Healthcare, we have a proven process for developing medical apps in compliance with crucial European regulations.We will make sure that your medical software is created time-efficiently and with patients and healthcare practitioners in mind.

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?

Do you struggle 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:

How Revolve can help you with  medical software development?

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.

Not sure about the type of service you need?

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.

How do we do it at Revolve Healthcare?

See the companies that trusted us.

Medical software projects we’ve worked on

What do our clients think?

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

Let’s talk about your 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.

What you should know about standards and requirements for medical software

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.

We are ISO 13485 certified

Our Experts

We can discuss them during the Discovery Meeting:<ul><li>How can we help you bring your idea to life</li><li>What are common medical software development challenges </li><li>How our team works on medical software development </li><li>How do we maintain compliance with international standards </li></ul>Fill in the form to book a discovery meeting and get a face to face explanation of the topics above.

Do you have more questions on medical software development?

Check out our articles on medical software development. 

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

Medical Software

If you're a professional in the pharmaceutical sector looking for a custom pharmaceutical software development partner to take charge of your project, from concept and design to app/system development — or even to manage everything end-to-end — Revolve Healthcare is your destination.We specialise in developing custom pharmaceutical software solutions that not only meet your specific needs but also prioritise both healthcare professionals and patient-centred approaches.

Digital Transformation for Pharma

Our apps are used by

With our comprehensive omnichannel platform development services, you can effortlessly connect with your audience across all devices, disseminate your content through various platforms, scrutinise the impact of your efforts, and refine your strategy for omnichannel engagement with automation. 
Here's how we can transform your business:

Omnichannel Engagement Solutions 

Book a call to discuss together your pharma challenges

Software for Digital Pharma Transformation

In the rapidly evolving landscape of healthcare, digital pharmaceutical solutions stand at the forefront of transforming patient care and industry standards. These innovative technologies offer a multitude of benefits, revolutionising the way pharmaceutical companies interact with their customers, manage data, and ultimately, deliver care.

Benefits of Digital Pharmaceutical Solutions 

Do you want to understand more in-depth how technology can help your business?

Digital Pharma Blogposts

Revolve Healthcare, prioritising clear communication, honesty, and teamwork, directly supports pharmaceutical companies in adopting digital technology. We keep up with the latest industry trends and innovations, providing our partners with current best practices and advancements in digital transformation to help them remain ahead in a rapidly changing market.

We are ISO 13485 certified = quality process for your pharma software development 

Book a call to begin.Wladyslaw Cwirko&nbsp; Business Development Manager

Let's discuss and address your challenges together

Schedule a Discovery Meeting with us to uncover the potential of your software project together.What is a Discovery Meeting?<ul><li>It's a free video call with Wladyslaw and our technical expert, ready to tackle all your software inquiries,</li><li>The session can range from 20 to 45 minutes, tailored to suit your requirements, </li><li>This meeting is dedicated to addressing your queries related to custom software development, </li><li>No obligations involved; our goal is to assist you. </li></ul>

Let's talk about custom pharmaceutical software!

Digital Pharma

If you're a biotech industry professional looking for a trusted custom biotech software development company that can help you manage your project, conduct product design, develop the app/system, or all at once you've come to the right place.At Revolve Healthcare, we specialise in developing custom biotech software that is tailored to meet your specific needs in a humane, well-managed way.

Custom Biotech Software Development&nbsp;

Are you looking for suitable biotechnology software, but there isn’t quite what you need on the market? Or maybe you need to automate your processes? Here are some examples of what we could help you with:

We can deliver customised biotech software tailored to you needs

No worries. We didn’t want to get you bored, so these are just some examples. Let’s discuss your case and the solution you need - no strings attached.

Need help with another type of software?

Here are some examples of biotech SaaS companies and companies in other fields related to biotech that we’ve worked with:

Biotech-related projects we've worked on

What our medtech clients say

We can organize a friendly one-on-one call for you to hear their feedback firsthand.

Curious about our clients' experiences?

We offer a specialised team with a deep understanding of the biotech sector and its software demands. Roles such as project managers, developers, and testers are often filled by individuals with academic backgrounds in Biotechnology, Biomedical Engineering, Bioinformatics, and Chemistry.By empathising with your situation, they can provide the most helpful advice and facilitate smoother collaboration. &nbsp;Also, every member of our team is fluent in English.

We care about specialised biotech software development team

We believe in keeping biotech software aligned with the modern world. That’s why we apply the latest practices and technologies to develop high-quality, secure software solutions.We put great effort into code reviews and quality assurance that’s especially needed in life science software environments such as the biotech industry.

The latest technology and top-quality for your biotech software

Book a free discovery meeting, and let’s find out the possibilities of your software together. You're also welcome to request a reference call or inquire about anything else you need.What does a discovery meeting mean?<ul><li>It’s a free video call with Daniel or Czarek (one of our Partnership Managers) and a Tech Expert</li><li>It’s for you and any questions you have in the area of custom software development </li><li>It takes about 45 minutes to an hour, depending on the topic </li><li>No strings attached, we’re here to help!</li></ul>

Chat about your custom biotech software with us!

Great biotech software development is more than just coding. Our team is here to offer you more than just a service. Think of us as your managed team: developers who sync up perfectly, keep you in the loop with regular updates and always stick to deadlines. They work independently but are well guided by a Project Leader.We're all about getting things done right, saving you time and taking the stress off your shoulders. Here's a quick look at the benefits you get when you work with us:

We know how to work with biotech

Meet some experts from our team:

We proudly hold&nbsp;ISO 13485 certification, ensuring quality management system in medical device design and manufacturing. Our development aligns with standards like IEC 62304 and IEC 62366. As HL7 International member, we actively contribute to global healthcare interoperability standards.If your custom software needs to comply with medical standards - we've got you covered!

ISO 13485 certified = quality process for your custom biotech software development

We're Revolve Healthcare, an ISO 13485 certified software development company. Our work focuses on life science, healthcare and medical software development. Creating neat &amp; reliable applications is what we enjoy doing every day and want to help you with.We truly care about your work and the people behind it. Count on us for expert advice and a strategic approach to your software goals. We prioritize open communication for crafting exceptional applications and maintain an honest partnership, supporting you every step of the way.

About Us

Let’s find out together. What exactly can you learn from a discovery meeting?<ul><li>How we can help you scale your biotech prototype</li><li>What are typical software development challenges that biotech companies can face </li><li>How we can help you onboard a managed team to develop your solution </li><li>How to build a successful software </li><li>How to overcome the challenges of incorporating remote teams </li></ul>Fill in the form to the right and book a free discovery meeting to exchange our thoughts. We can’t wait to get to know you!

Not sure if that’s what you’re looking for? 

BioTech

Navigating the transition from wellness applications to regulated medical products requires a partner that integrates compliance into the engineering lifecycle. Revolve Healthcare provides the technical depth and regulatory oversight necessary to secure MDR and FDA approvals without late-stage redesigns.

FemTech software development

<ul><li>50+ Engineering &amp; Regulatory Experts</li><li>4.9/5 Client Satisfaction Rating</li><li>ISO 13485 Certified Quality Management</li><li>MDR/FDA Compliance-Ready Delivery</li></ul>

Why Revolve Healthcare delivers regulatory-first excellence 

The FemTech market is projected to reach $19 billion by 2031, with a 14-16% CAGR. As products move from consumer wellness to clinical diagnostics, the definition of a "best" partner shifts from UX speed to regulatory durability. This transition often involves processing more sensitive health data, increasing both regulatory expectations and the potential impact of security failures. According to ASPR, healthcare data breaches cost an average of $10.93 million per incident, making security-by-design a non-negotiable criterion.

What makes the Best Software Company for FemTech? 

Revolve Healthcare operates as a technology partner rather than a generic agency. We lead the software, compliance, and delivery workstreams together to reduce the execution burden on your team. Sustainable growth in MedTech is driven by specialised expertise rather than commodity services.Regulatory-First Delivery. We develop software and documentation in parallel. <a target="" rel="" href="https://link.springer.com/content/pdf/10.1007/978-3-032-03577-6_10.pdf">This often results in a 30% reduction in time-to-market</a> for regulated products by avoiding post-hoc documentation cycles.In-House Regulatory Team. Our engineering team works alongside an in-house regulatory department. This creates a feedback loop where compliance requirements inform technical architecture in real-time.Operational Ownership. We take operational ownership of the development lifecycle. However, we maintain transparent decision-making so you never lose strategic control over your FemTech product.

Why Revolve Healthcare Leads in MedTech Execution 

Trust in MedTech is built on verified performance. Revolve Healthcare has been recognised for its continued expansion within the highly regulated healthcare sector. Our growth is built on medical device software expertise and long-term partnerships with healthcare organisations seeking specialised support.Revolve Healthcare has been listed in the FT1000: Europe’s Fastest-Growing Companies 2026. This ranking recognises organisations that have achieved outstanding revenue growth across Europe through independently verified financial data.

Awards and Recognition for Medical Software Excellence 

What Our Partners Say

Selecting a partner for a regulated product is a risk-management decision. Follow these five steps to ensure your software meets clinical and regulatory standards.

How to Choose the Right FemTech Development Partner 

Revolve Healthcare is recognised as a fastest-growing medical device software company in Europe. Our inclusion in the FT1000 2026 confirms our operational maturity and ability to scale while maintaining strict healthcare standards. For FemTech companies moving from wellness to medical-grade products, we offer a path to audit-readiness that minimizes risk and maximizes clinical impact.

Why FemTech leaders choose Revolve Healthcare

We actively support local initiatives connected with women’s health and digital healthcare innovation. Revolve Healthcare is also a partner of <a target="" rel="" href="https://www.femtechpo.pl/">“FemTech po Polsku” (eng. FemTech in Polish/FemTech, Polish-style)</a>, supporting the growth of secure, scalable, and compliance-ready healthcare products within the Polish FemTech ecosystem.

Supporting local FemTech initiatives 

Agata Neale-Orzechowska Polish FemTech Community Leader0048 792 018 663 <a target="_blank" rel="" href="mailto:agata@revolve.healthcare">agata@revolve.healthcare</a>

Let's Talk

FemTech

Małgorzata Gonsior-Kustosz, PhD

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<h1>MDR Rule 11: Classification </h1><h1>Rules for SaMD with their </h1><h1>benefits and challenges</h1>

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<h1>Medical Device Regulation (MDR) and its consequences for healthcare software development</h1>

Web, Mobile & Desktop

Product Design

Regulatory Consultations 

MDR Readiness Audit

Cybersecurity & Data Privacy

Quality Assurance & Testing

Firmware Services

Medical Device Interoperability

Cloud & DevOps

Medical Software Maintenance

Medical Device Regulation (MDR) and its consequences for healthcare software development  Innovating in the healthcare industry means improving people’s lives through technology. But it also means adhering to regulations that ensure the solutions you create are safe for the patients – in many different ways. Medical Device Regulation (MDR) is probably the most important set of rules you need to follow when building a medical app which would be launched on the European market. The term medical app in this article means a medical app, a medical device, according to the MDR. Let’s dive into why it exists, what it means for the health tech sector, and why you should get familiar with it.   MDR, Medical Devices and their characteristicsBefore discussing how MDR influences software development, we should know what MDR itself and medical devices are.The Medical Devices Regulation (MDR) (EU 2017/745) is a regulation that details the requirements for the production of medical devices. Meeting these requirements allows for placing on your product the CE mark - only then can you sell it as a medical device within European countries. According to MDR, a medical device is “any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used (...) for the specific medical purposes” such as:diagnosis, prevention, monitoring, prediction, prognosis, treatment, alleviation of, or&nbsp;compensation for disease, injury, or disability,investigation,&nbsp;replacement, or modification of the anatomy or a physiological or&nbsp;pathological process or state,providing information&nbsp;by means of in vitro examination of specimens derived from the&nbsp;human body, including organ, blood, and tissue donations,and which does not achieve its principal intended action by pharmacological, immunological, or metabolic means in or on the human body but may be assisted in its function by such means.In addition, medical devices are devices for the control or support of conception and products intended to clean medical devices.  Accelerating the health technologiesAlthough embedded software, as well as desktop, web, and – more recently – mobile applications have been supporting medical professionals and patients for many years now, it has been the COVID pandemic that accelerated the medtech sector.These e-health apps range from calorie counters and pedometers (counting your steps) to blood glucose monitors and remote electrocardiogram (ECG) monitoring, which may also be connected to an electronic health record (EHR). Family planning apps (some use AI algorithms based on a woman’s menstrual cycle pattern, basal body temperature, and ovulation tracking with at-home ovulation tests) have gained popularity recently and there are several professional debates about whether they can be considered a form of contraception. Healthcare professionals often use apps with calculators, e.g. to estimate one’s risk of coronary artery disease or pre-eclampsia in pregnancy. There are several apps that support the diagnosis of skin diseases and help non-radiologists interpret imaging studies. And many, many more.  Mobile apps as medical devicesIt’s possible you’re using several medical apps every day without even realizing that many of them are now considered medical devices. As a user, you don’t exactly need to be aware of the consequences of this, but as a company creating an app that may fall into this category, you definitely should.So, how do you know if your medical app is a medical device and falls under the Medical Device Regulation?The main criterion to determine if your app is or not a medical device is its intended purpose. For example, an app collecting and analysing data on a person’s physical activity to maintain their general well-being, such as weight loss, is qualified as a general well-being app and falls out of the medical devices legislation. However, the same app collecting and analysing identical data for a medical purpose, such as controlling and managing eating disorders or diabetes, would be considered a medical app.    MDR and app classificationYou should be aware that the legal requirements for medical apps (considered in most cases as standalone software) have increased with the new MDR laws. The EU Medical Device Regulation (2017/745) has replaced the EU Medical Devices Directive (MDD) and established a regulatory framework for medical devices that safeguards public health and safety while supporting the market's competitiveness. The EU MDR came into force on May 26, 2021. However, the obligation for medical device manufacturers to comply with the new provisions of the MDR Regulation is valid from 26 May 2021. The classification of medical devices no longer depends solely on the labelled purpose of the device but also the inherent risks of the devices. This leads to significant implications for medical devices since many fall into higher classification rules.The new MDR classifications reflect a medical device's potential risk of harm. MDR divides medical devices into four classes of risk: I, IIa, IIb, and III. Class I devices are considered the lowest risk, whereas Class III are deemed high-risk devices. According to MDR, software may be a medical device of the highest-risk class (class III). Importantly, this includes stand-alone software (software that can work offline or is a portable application). For example, an app that helps users calculate drug doses would be a Class III medical device because the potential errors pose high risks for the app’s users. You can find more examples and see what Class your software falls into on our website here.    Rule 11 and risk assessmentIn the MDR (Annex VIII), we will find 22 rules for the classification of medical devices grouped into four categories:Rules&nbsp;1-4 consider non-invasive devices.Rules&nbsp;5-8 consider invasive devices.Rules 9-13 consider active devices (any device that depends on a source of energy other&nbsp;than any device that depends on a source of energy other than the human body).Rules 14-22 are so-called ‘special rules’ as they refer to medical devices which do not fit&nbsp;into the above categories.Every rule discusses how specific medical devices fit into new, stricter risk classifications. However, Rule 11 is most important for manufacturers of medical device software (MDSW).Rule 11 describes and categorises the risk of software based on the combination of the significance of the information provided by the software to the healthcare decision and the healthcare situation or patient’s condition. According to Rule 11, in general, software intended to provide information which is used to make decisions with diagnosis or therapeutic purposes is classified as class IIa – for example, software intended to rank therapeutic suggestions for a health care professional based on patient history, imaging test results, and patient characteristics.Of course, there are exceptions where the use of medical software may or must entail a greater risk for the patient or user. In situations where the effects of the decisions may result in death or an irreversible deterioration of a person's health, the software should be classified as class III. If decisions have an impact that may cause a serious deterioration of a person's state of health or surgical intervention, the software should be classified as class IIb.All other software, being medical devices, is classified as class I.If the software is independent of any other medical device, it shall be classified in its own right – it concerns most medical apps. On the other hand, software which drives a device or influences the use of a device shall fall within the same class as the device.You can read more about Rule 11 and risk classification here.  The impact of MDR on the medical devices services marketPatients should feel confident that the medical devices are safe and effective. However, such a comfort state demands stricter regulations, like those included in MDR.MDR introduces many requirements that manufacturers must meet, such as:development and refinement of quality and risk managementundergoing more rigorous demands for launching a medical device which will ensure&nbsp;that medical devices are safe for the patientsproviding their medical device with a UDI identifying code and registering it in the&nbsp;EUDAMED base, which makes it easier for authorities to monitor the deviceproviding post-market evaluations and reports.What’s more, MDR sets a challenge for manufacturers whose medical devices used to be in class I due to MDD and now belong in class IIa or IIb. They had to CE mark their devices before May 26th, 2021, or use a transition period from MDD to MDR described in Article 120 of MDR.Nowadays, developing software as a medical device within the law of MDR might seem time-consuming, like a time-consuming process. Nevertheless, MDR provides more clarity to rules for providing CE certification. MDR brings more transparency into manufacturing medical devices and preparing the necessary documentation. Also, we should remember that those regulations bring the most important thing to people – safety.  Moving forwardTo sum up, for the proper classification of the software medical devices, it is necessary to consider the intended purpose, intended population, context of the use of the software and the information provided by the software, as well as the possible consequences of any taken decisions. MDR imposes stricter regulations on medical device services, reclassifying some devices, introducing new requirements for manufacturers, and emphasising safety.In this article, we’ve covered the basics of MDR and why it’s relevant for you if you’re building health-related software. In later articles, we will follow how MDR influences the software development process and what you should pay special attention to if you want your app to be MDR-compliant.

Małgorzata Gonsior-Kustosz, PhD

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