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

We’re starting a new project alongside a company that has nearly 200 years of excellence in infection control 🎊 We’re excited to announce our new collaboration with Eschmann Technologies Ltd, a company with nearly two centuries of expertise &  leading manufacturer of autoclaves in the UK in infection control. Together, we’ll be developing advanced software solutions that align with the highest standards of safety and regulatory compliance in healthcare. By bringing together Eschmann’s legacy and advanced technology, this project will set new standards for infection control. The collaboration focuses on delivering innovative solutions that meet today’s healthcare challenges while ensuring the highest levels of regulatory assurance. Looking forward to the journey ahead! #HealthSoftware #MedicalTechnology #iso13485 #InfectionControl #HealthTech #MedicalD #MedTech #MedicalDevices #SoftwareDevelopment #PublicHealth #UK

⚕ mHealth – Belgian DTx reimbursement system mHealth Belgium (mobile health Belgium) is an initiative of the Belgian Federal Government, which has been active since the 25th of January 2019. It allows companies which developed CE-marked medical devices to have their DTx reimbursed in Belgium. What is the mHealth pyramid? When you read about mHealth Belgium, you might come across the words "mHealth pyramid". The Belgian mHealth reimbursement scheme consists of a three-level validation process presented in a pyramid graphic form. Hence, the name. The first level (M1) requires a manufacturer to provide a CE-marked app which complies with GDPR. FAMHP (Federal Agency for Medicines and Health Products) will check if the app complies with the regulations during this level. The second level (M2) is when the risk assessment happens. What does it mean? Your app will be checked in terms of data security and interoperability. You can read more about this process in the criteria description provided by the Belgian government. On the third level (M3), companies should provide clinical evidence and socio-economic value. The third level is divided into two categories. Level 3 light – an app is proving its socio-economic value and being temporarily financed by NIHDI (National Institute for Health and Disability Insurance). Level 3 plus – an app has proved its socio-economic value and is fully financed by NIHDI. You can read more information on DTx reimbursement in Belgium and other European countries here -> bit.ly/47VWaPo #medtech #softwaredevelopment #medicaldevices #mhealth #mhealthbelgium #digitalhealth #healthcare  Picture retrieved from: https://lnkd.in/dfBM-jTZ

🌟 Navigating the complexities of medical software compliance doesn't have to be a headache Our co-founder & co-CEO Przemek Grzywa, delivered a Masterclass at the Lohmann & Rauscher Accelerator Kickoff, focusing on #MDR (Medical Device Regulation), #SaMD (Software as a Medical Device), and #DiGA (German Digital Health Applications on Prescription).   We're always excited to share our expertise and collaborate with healthcare innovators to bring their projects to life. The reason why we like to elaborate on these topics as a software company is what sets us apart - our in-house regulatory team, enabling us to go beyond compliance and create solutions that meet the highest standards. We put a lot of effort into making sure you get all the information in a digestible content form, so if you'd like to have a bite of what Przemek spoke about, pick and mix what you need: MDR -> https://bit.ly/mdr-revolve SaMD -> https://lnkd.in/df6qzMh4 DiGA -> https://lnkd.in/d9dkAYYF Many thanks to Laura Ihrlich for the invitation and opportunity to contribute! #MedicalSoftware #HealthcareInnovation #ISO13485 #RegulatoryCompliance #SaMD #DigitalHealth #MDR #HealthcareTechnology #SoftwareDevelopment #MedTech #LohmannRauscher #Masterclass #DTx #MedTechStartups #CECertification

Our client, Martti Nirkko, R&D and Data Scientist at obvioTec AG, summed up our collaboration. We helped obvioTec with parts of the desktop app development, automating #pharmaceutical quality control. Our recommendations for #software solution automated tasks, optimised processes, and enhanced efficiency by integrating measurement devices into a centralised system. Through technical consultations, we demonstrated how to significantly reduce measurement time. Learn more about the project from our case study ➡️ https://bit.ly/3KmLqzF

October is Breast Cancer Awareness Month—how can digital health solutions support?🌸 Breast cancer is one of the most common cancers worldwide, affecting millions of women every year. Early detection, timely treatment, and ongoing support are critical in improving survival rates. That’s why Breast Cancer Awareness Month is so important—it not only raises awareness about the disease but also highlights the need for innovation in care. For FemTech and MedTech companies, this is a crucial opportunity to develop solutions that enhance diagnosis, treatment, and patient wellbeing, ensuring that technology plays a key role in fighting this battle. We’re inspired by companies like Prosoma, whose platform offers psychological support to cancer patients, helping them navigate the emotional challenges of their journey. This is just one example of how software can play a crucial role in the holistic treatment of breast cancer. #BreastCancerAwareness #HealthTech #MedTech #FemTech #MedicalDevice #CancerCare #RevolveHealthcare #MedicalSoftware #HealthcareInnovation

Master IEC 62366 standards for safer medical devices ✅ IEC 62366 is an international standard that “specifies a process for a manufacturer to analyse, specify, develop and evaluate the usability of a medical device as it relates to safety”. This standard is divided into two parts: IEC 62366-1 – the first document depicts the application of usability engineering to medical devices, IEC/TR 62366-2 – the second part is a guidance on the application of usability engineering to medical devices. 🔗 Check more on our blog and learn how we can help you meet this and other standards! https://bit.ly/3ZcBFfN #MedicalDevices #IEC62366 #HealthcareSoftware #MDR #FDA #MedicalSoftware #HealthcareSoftware

🧠 World Mental Health Day: Let’s focus on meaningful solutions, because mental health deserves more than a ‘quick fix’ On this #WorldMentalHealthDay, we’re highlighting the advancements that are transforming mental health care. At Revolve Healthcare, we’re proud to have worked with several impactful projects, helping to create software solutions that provide tangible benefits: ylah: A blended psychotherapy platform offering personalised support for professionals and patients. ABAStroke: A system that aids stroke recovery through tailored care and monitoring. ALTA sp. z o.o. : A platform connecting psychological tools with HR processes, integrating mental well-being into advanced IT solutions. e.rupt: An application for personalised treatment of erectile dysfunction, using cognitive behavioural exercises for self-empowerment. We remain dedicated to delivering reliable solutions that meet the highest medical standards, supporting mental health through innovation. Let’s continue to innovate and support mental health, not just today, but every day. #MentalHealth #HealthcareSoftware #DigitalTherapy #SaMD #BlendedPsychotherapy #MedicalApplication #HealthSoftware #CECertification #SoftwareAsAMedicalDevice #CBTExercises #MentalHealthTech #WorldMentalHealthDay2024

💊 How does pharmaceutical software contribute to the #digitaltransformation within pharmaceutical companies? The role of pharmaceutical software development in digital transformation is pivotal in reshaping the landscape of the pharmaceutical industry. Here are several vital aspects highlighting its significance: #PharmaTech #Pharma #Pharmaceutics #FutureOfPharma Or read the full blog post and explore how the right technology can move your business forward: https://bit.ly/4dApoVP 

💊 The future of pharma is digital, and it’s evolving faster than ever. In our latest blog post, by Władysław Ćwirko, we take a closer look at how software solutions are revolutionising the pharmaceutical industry—boosting efficiency, enhancing patient outcomes, and ensuring regulatory compliance. The innovations are reshaping everything from #medicine development to supply chain management. Curious about how digital solutions can advance your work in #pharma? Read the full post and explore how the right technology can move your business forward: https://bit.ly/4dApoVP #PharmaTech #DigitalTransformation #PharmaceuticalSoftware #HealthcareInnovation #MedTech #PharmaSolutions #FutureOfPharma