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Revolve Healthcare

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Polska
Katowice
Revolve Healthcare

We're an ISO13485-certified custom software development company for & industries.

27/06/2025

Healthcare systems talk — but do they truly understand each other? Meet the 4 levels of interoperability

(Healthcare Information and Management Systems Society) is an American organisation that aims to improve the quality of healthcare. They divide into four levels:

1️⃣ Foundational Interoperability
2️⃣ Structural Interoperability
3️⃣ Semantic Interoperability
4️⃣ Organisational Interoperability

What’s their aim? To make sure that you provide high-level data protection and privacy 🔒

🔗Do you want to learn more about those levels? Read our article: https://bit.ly/46jBIK7

26/06/2025

Critical supplier – the trickiest term to define? 📖

Notified bodies talk about it, software developers talk about it, and regulatory affairs specialists talk about it – yet you won’t find the definition in ISO 13485, MDR, or IVDR. So, who is this mysterious critical supplier?

➡️ It’s a company that you, a legal manufacturer, bring in to help you develop medical software. The “critical” part comes from the fact that this company’s potential malfunction can pose a risk to the users of your device❗

During an audit, a notified body might ask you about critical suppliers, as ISO 13485 demands a risk-based approach to managing suppliers, especially those providing critical components.

🔗 Want to learn more about critical suppliers? Read our blog article: https://bit.ly/3GgckKI

27/05/2025

Jak łączyć oprogramowanie medyczne z farmakoterapią, aby zwiększyć skuteczność leczenia i wartość terapeutyczną leków?

To właśnie temat naszego wspólnego wydarzenia z kancelarią DZP, które odbędzie się już 5 czerwca w Warszawie.

Wraz z ekspertami z obszaru prawa, technologii i cyfrowych terapii (DTx) porozmawiamy m.in. o:
🔹 rozwoju oprogramowania jako wyrobu medycznego (SaMD),
🔹 projektowaniu aplikacji zgodnie z MDR i innymi regulacjami,
🔹 jak skutecznie łączyć oprogramowanie z farmakoterapią,
🔹 wyzwaniach prawnych i technologicznych w obszarze farmacji.

W panelu ekspertów znajdą się przedstawiciele Revolve Healthcare:
– Przemek Grzywa, nasz współzałożyciel i co-CEO, który opowie o potencjale nowoczesnego oprogramowania medycznego,
– Władysław Ćwirko, ekspert od wdrażania cyfrowych rozwiązań w branży farmaceutycznej.

Swoje doświadczenie i perspektywę przedstawią także:
– dr Mateusz Mądry, Partner, Szef Praktyki Life Sciences w DZP
– Marek Paluch, Senior Associate w Praktyce Life Sciences w DZP
– Emanuela Kufel, współzałożycielka Prosoma
– Dawid Maj, ABAStroke

📍 Kancelaria DZP, Rondo ONZ 1, Warszawa
📆 5 czerwca, godz. 9:00–12:30
📝 Rejestracja do 2 czerwca: https://bit.ly/3FaR6gZ

Do zobaczenia!

21/03/2025

Our ebook on collaboration between regulatory affairs specialists and software developers is here 📖

Compliance or agility? Why not both? Our ebook on in scrum is out now 📖

What will you learn from the guide?
💡 Where to start with mixing Scrum methodologies with IEC 62304
💡 Ways of encouraging developers to embrace documentation as part of their workflow
💡 How to enhance communication between developers and regulatory specialists for better teamwork
💡 How to prepare documentation that meets Medical Device Regulation requirements without delays

Ready to find out more?

🔗 Download free ebook here » https://bit.ly/4kOGlkq

28/08/2024

What is accessibility in healthcare apps? 🤔

The European Commission defines accessibility as a precondition to ensure that people with disabilities can fully and equally participate in society.

When we discuss accessibility in healthcare apps, we should mention web accessibility, which means that “websites, tools, and technologies are designed and developed so that people with disabilities can use them".

Essentially, accessibility is about making your healthcare app usable by all people, no matter their potential disabilities, through maintaining a comprehensive and positive User Experience, fostering empathy towards the end-users.

Read more about accessibility on our blog -> https://bit.ly/4cE3kt2

13/06/2024

🏗 What is the Technical Documentation in the process of the medical software certification?

One of the crucial and mandatory steps of the conformity assessment process is preparing the Technical Documentation.

Technical Documentation (sometimes called Technical Files) is a list of documents required from the manufacturer when attempting to get a CE mark. The list is complex; however, it is necessary to maintain the highest levels of the app's safety. So what does conclude to the Technical Documentation?

📑 Device description and specification, including variants and accessories
📑 Information to be supplied by the manufacturer
📑 Design and manufacturing information
📑 General safety and performance requirements
📑 Benefit-risk analysis and risk management
📑 Product verification and validation

To understand more in-depth what exactly is required read our blog ->https://bit.ly/3XELjHl

16/05/2024

🤳 Starting a journey? Begin with expertise.

Yesterday, our CEO Przemek Grzywa spoke at Vitalis, Scandinavia's premier e-health conference, on "DTx - from Idea to Market". Here's a glimpse of the insights shared:

DTx as Medicine: Just like a traditional pill, DTx must be evidence-based and clinically evaluated.

Compliance: Rigorous requirements and industry standards (IEC62304, IEC62366, ISO13485, GDPR) must be met.

Challenges: The journey is long, demanding, and costly but, in the end, very rewarding.

Reimbursement: Countries are beginning to reimburse DTx costs, meaning you might save funds if you plan it right.

Commercialization Strategies: Various strategies exist, such as those implemented by ABAStroke, Prosoma, Endo Health GmbH, HelloBetter, Kaia Health, Mawendo GmbH, NeuroNation - Mind & Brain Health Technology, Selfapy, and Sidekick Health.

Our expertise in medical software development ensures a streamlined process from concept to CE mark approval, typically taking from 18 months.

Interested in starting your DTx journey? Contact us for a free one-hour regulatory consultation👉https://bit.ly/3TpQjf7

Photo credit: Tingquan L., TheraBuddy.

30/04/2024

Exciting news for digital health in the EU 🚀🩺

The European Parliament passed the European Health Data Space (EHDS) regulation.

It’s a really important decision for . Why?

✨ It will revolutionise access to electronic health data, allowing individuals to retrieve their records through patient portals or apps.

✨ EHDS ensures data portability across EU borders, allowing patients to access care seamlessly across the EU.

✨ The electronic health record systems will be certified to guarantee compliance with interoperability and logging requirements.

✨ It will accelerate research and innovation in the EU, contributing to the development of new treatments and advanced health solutions.

Introducing EHDS will revolutionise access to electronic health data, promising a future of interconnected health data for patients and healthcare professionals.

Can you think of other benefits of EHDS?

29/04/2024

MedTech in discussion: what's really important? 🤔

On Friday, Daniel attended Product Café Poznań organised by PDMA Central Europe, a meeting focused on building products, paying attention to the medical regulations, certification, new technologies and the UX based on user's needs.

Daniel participated in two inspiring lectures by:

🔷 Honorata Hafke-Dys (StethoMe), who shared her experience with breaking into the medical device market as a startup and the journey from the idea of the product to applying for MDR certification.

🔷 Piotr Strychalski (eGabinet.pl) highlighted that dialogue is crucial to connecting medtech innovators and clinicians and presented examples of such communication.

Product Café values an atmosphere of openness and free discussion, so after the lectures, the attendees had a chance to ask questions and exchange their views during networking sessions.

In your view, what are the most important aspects to remember while entering the medtech market?

If you are thinking about building your medical software, check out how we can help you ➡️ https://bit.ly/4ax4ZQJ

26/04/2024

🖐 Meet our People team 🖐

This week, let’s take a look at our People team. Magda, Ania and Ewa ensure that Revolve runs well from the inside and outside, taking care of the company's values, work culture and work environment.

Here's what they do:

🌞 Happiness Lab: Magda & Ania make great efforts to make everyone feel great at Revolve. We're currently having the fifth edition of the Happiness Lab project, focusing on the overall happiness of our team.

🤝 Friendly recruitment and onboarding process: The People team takes care of both candidates and newbies to make the recruitment process as friendly as possible, warmly greeting our new employees and making them feel at home.

📄 Paperwork: They oversee our documents, contracts and benefits so we don't have to worry about paperwork. They also deal with accounting and invoice processing.

📅 Organising delegations, parties and conferences: The People team plans every event, in detail so that we can work smoothly or have fun together.

🍬 Guardians of our office: They make sure that our office is clean and running like clockwork, and that we have supplies of stationary, sweets, and cold beverages.

📱 Social media experts: The People team regularly posts on Instagram and Facebook so you can enjoy insights into our daily office life.

What else do the People team do at your company?

25/04/2024

Digital DNA – the future or the present? 🧬🤔

The 25th of April is World DNA Day, the occasion we celebrate the discovery of DNA's structure, which revolutionised genetics 🧬

In 1953, the discovery of the double helix revolutionised our grasp of life's code. Today, digital tools enable modelling, optimising genome engineering, and conducting evolutionary experiments via mobile systems.

But is digitising DNA possible? Absolutely! DNA can be sequenced into digital data, stored in databases, and utilised for genetic research, medical diagnostics, and forensic analysis.

With our client ENPICOM, who's advancing biotechnological research for personalised immunotherapies and vaccines by decoding the immune system, we developed a cloud platform that enables scientists to manage, analyse, and visualise immune repertoire sequencing data.

Here's how we approached the project ➡️
https://bit.ly/3qggVVo

Do you know any applications?

24/04/2024

"Regular" vs "non-regular software development – let's take a closer look 💻👀

Firstly, let's make clear what "regular" software means to us.

In simple terms, "regular" software is used in various industries that don't require certification.

A "non-regular" is medical software compliant with IEC 62304, specifically designed for healthcare applications, adhering to regulatory standards to ensure safety and effectiveness in a medical context.

The main difference is following IEC 62304's requirements. Starting early with full compliance with the standard saves time, money, and stress. Delaying could mean tackling each requirement separately, making things complex and expensive.

Our advice? Include the standard rules in your software development from the start to make sure your medical software is safe and works well.

How to start? Why not book a free one hour of our Regulatory Consultations to talk through the issues of regulatory compliance 🤔

Book here ➡️ https://bit.ly/3TpQjf7

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