Revolve Healthcare

Regulatory Consultations - free one-hour consultation available! 💼 🤳 Navigating the complexities of regulations and standards for your #SaMD app, software, or system can be daunting. The challenge grows with documents spanning hundreds of pages in complicated legal jargon. We're here to assist in demystifying the starting points and necessary steps, and the goal is to make MedTech more accessible by supporting businesses with our expertise in compliance for #medicalsoftware projects. Should this align with your needs, a complimentary one-hour consultation is offered to provide high-level guidance at the outset of your #compliance journey. Secure your slot -> https://bit.ly/3Pj99Dm #healthcaresoftware #digitalhealth #digitaltherapeutics #medicaldevice

Did you know? 🤔 In a document prepared by the TÜV AI.LAB, we find the abbreviation AIMDSW, which stands for Artificial Intelligence in Medical Device Software. Although AIMDSW is not yet commonly used, it’s worth remembering this abbreviation as the number of usage of AI in healthcare grows. Get to know more about AI Act in medical software development from our blog https://bit.ly/463iHJP #aisoftware #medai #healthcareai #medicalsoftware #samd

We are pleased to share that Przemek Grzywa was one of the speakers at Polish-German Economic Forum last week. This event organised by AHK Polska, Polish Investment and Trade Agency (PAIH) and Ministerstwo Rozwoju, focused on the question "Is there potential for Poland to become a pharmaceutical logistics and manufacturing hub?". Przemek debated together with: 💊 Sebastian Szymanek, CEO of Polpharma, 💊 Anna Krzyżanowska, Head of Governmental Affairs and Market Access at Merck Group 💊 Dariusz Gurtowski, Manufacturing Scientific and Technology Director at BIOTON S.A. 💊 All led by Katarzyna Panfil, Polish Investment and Trade Agency (PAIH) The forum provided a valuable opportunity for exchanging insights and fostering collaboration on critical topics impacting the healthcare industry, in this case #pharmaceuticals, especially as Przemek focused on the perspective of #DigitalTherapeutics. We are proud to have been part of this event and look forward to continuing our mission. #dtx #medicalsoftware #medicalapp #healthcareapp #healthcare

What is the AI Act and how does it affect healthcare industry? We're coming with another piece of regulatory information - this time on the AI Act, and its influence on the healthcare industry, specifically medical software development. 🔍 What's Inside: - how the AI Act is setting new standards for healthcare innovation, - the potential benefits and challenges of integrating new standards into process practices, - the correlation between MDR/IVDR and AI Act classes, - requirements for compliance with AI Act. This is a must-read for anyone interested in the future of #medicalsoftware and the role of AI in shaping it. 📖 Read the full article here: https://bit.ly/463iHJP #healthcaresoftware #mdr #aiact #ai #digitalhealth

Exciting News! We're thrilled to announce another collaboration with the Medical Innovation Institute! Together, we're on a mission to accelerate the digitisation of healthcare systems by providing #digitalhealth tools. Our expertise in co-creating innovative solutions for the #pharma sector ensures seamless adoption of their products within the healthcare ecosystem. Our services enable the rapid integration of new technologies into everyday medical practice, significantly enhancing the quality and effectiveness of treatment. This partnership uniquely combines the clinical knowledge of the Medical Innovation Institute's practising doctors with Revolve Healthcare's technical experts, who have extensive experience developing numerous digital health projects. Stay tuned for more updates! #medicaldevice #medicalapp #samd 

Meeting with our client YLAH – what made it special? Thrilled to share some highlights from the last week – we had the pleasure of hosting the Ylah team at our office for a series of productive workshops, brainstorming sessions, and, of course, some fun activities. In today's digital age, it's easy to rely solely on virtual meetings. However, the value of face-to-face interactions cannot be overstated. Here's why: 🤝 In-person meetings foster deeper connections and a clearer understanding of each other's perspectives, enhancing collaboration and innovation. 📊 Our product workshops with Ylah led to some exciting new ideas and developments for the future. Stay tuned for what's coming next! 🎉 We balanced work with play and shared meals, strengthening our bond and boosting team work. At Revolve, we combine the convenience of digital communication with the irreplaceable value of face-to-face meetings. How does your team balance digital and in-person interactions to drive success for medical software development? #MedicalDevive #Psychotherapy #DigitalHealth #ProductWorkshops #MedicalApp

🏗 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/45kpDSt #cemark #medicalsoftware #digitalhealth #technicaldocumentation #mdr #ce

🤳 Starting a #DTx 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/3Pj99Dm Photo credit: Tingquan L., TheraBuddy. #digitaltherapeutics #digitalhealth #medicalinnovations #medicalsoftware

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 #digitalhealth. 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? #EHDS  #healthcareinnovation #healthcarenews

💊 What are the digital solutions for pharma? 💊 Last week, Władysław attended a meeting with Aflofarm Farmacja Polska Sp. z o.o, organised by Górnośląski Akcelerator Przedsiębiorczości Rynkowej sp. z o.o. and MedSilesia Cluster - Silesian Medical Devices Network, to talk about digital transformation in #pharma. Learn more about how we help to transform your pharmaceutical solution ➡ https://bit.ly/49bCSVK     #digitaltransformation #medtech #pharmacy