Keep your finger on the pulse of medical software development, regulations, and innovations

• Medical Device Regulation (MDR),
• Digital Therapeutics (DTx),

How to get your digital therapeutic (DTx) reimbursed in Europe?

Have you developed a digital therapeutic and wonder how to reimburse it in European countries? You may have already heard about the German DiGA, but many other countries are also taking steps to introduce similar systems. Which countries are these? What requirements do they have? That's what today's text is about.

• Software Development,
• Software as a Medical Device (SaMD),
• Medical Device Regulation (MDR),

IEC 62304: a Step for Developing Safe Medical Software

Developing software compliant with IEC 62304 differs from building a regular one, primarily due to the regulatory requirements. This article explores the medical software development process, common challenges, and practical solutions. You’ll also learn how the regulations ensure patients' safety and the quality of the software.

• Software Development,
• Medical Device Regulation (MDR),

Ensuring safety in medical software: what is IEC 62304?

IEC 62304 is an international standard shaping the development and maintenance of medical device software. Preparing to build software? This article will give you an idea of how IEC 62304 ensures the creation of safe and high-quality software uncovering facts about the development life cycle, classification, risk management, and IEC 62304 interactions with other medical standards.

• Software Development,
• Digital Therapeutics (DTx),
• Medical Device Regulation (MDR),

What is a DiGA and why is it worth creating?

In recent years, we have observed the development of digital therapeutics (DTx) – software supporting patients through health issues. However, the growing number of health apps requires regulation. One of the first countries in Europe to take such action is Germany. Hence, today, we will talk about DiGA.

• Software as a Medical Device (SaMD),

What is Software of Unknow Provenance (SOUP)?

• Medical Device Regulation (MDR),
• Software as a Medical Device (SaMD),

MDR Rule 11: Classification Rules for SaMD with their benefits and challenges

Software development for medical devices has become significant with technology growth in recent years. However, improving patient care, diagnosis, and treatment through software as a Medical Device (SaMD) brings challenges, such as requiring specific regulations to ensure patient safety. Here enters MDR Rule 11, a crucial framework establishing Classification Rules for medical software. In this article, you will learn about the benefits and challenges associated with Rule 11, the criteria of MDR classification and the steps of deployment and regulation of SaMD applications.

• Revolve's Team,
• Managing Process,

Project Leader role at Revolve Healthcare

As a software company, we have an experience in launching and running projects, and because we launch about 10 greenfield projects every year, we know that the key person in the management process is a great leader. At Revolve Healthcare, we decided to blend the roles of Project Manager and Team Leader to create a hybrid - Project Leader. In this article, we will explore the role of Project Leaders, their responsibilities and daily tasks, and their value in a well-managed project.

• Medical Device Regulation (MDR),
• Software Development,
• ISO 13484 (medical devices),

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.

• Data Security,
• Software Development,

HL7 FHIR: Foundations in the architectural context

The Fast Healthcare Interoperability Resources (HL7 FHIR) standard describes how healthcare information can be exchanged between different computer systems. Seeing how already some 30% of the world’s data is generated by the healthcare industry – and a lot of it is highly sensitive – it’s no wonder this standard came into existence. Let me try to explain why it’s important and how it works from a software developer’s perspective.

• Digital Health,
• Med Business,
• MedTech,

Does outsourced software development make sense in healthcare?

Mobile and web app development has become an integral part of the healthcare industry. It benefits pharmaceutical companies, hospitals, clinics, and patients alike. This is not surprising. After all, almost everyone has a smartphone, so communication between medical staff and patients or the diagnostic processes can be significantly simplified.