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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.

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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.

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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.

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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.

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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.

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Patient consent and digital health data in GDPR and HIPAA context

Medical service provision is not only about the contact between the patient and the doctor. It’s equally important to evidence the visit properly and the medical procedures implemented. The information in the records is essential for the patient and the provision of further services – by other specialists or other facilities. Who can aggregate patient data, and on what basis? Do you need patients’ consent to use digital health data? Read on to find out.

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Why digital health applications (DiGA) are the future – in conversation with ABAStroke

Legislative developments in the MedTech markets aren’t progressing as fast as the technologies and innovations in it, but – especially over the last few years – they significantly sped up, opening new possibilities for digital therapeutics (DTx) apps and other healthcare software. One of the countries leading this change is Germany, with its simplified path for digital health applications (DiGA) to become reimbursable by the healthcare system.

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What complying with ISO 13485 means for medical software development – and for us

As a software development company, we don’t necessarily need to be compliant with external quality standards, but we want to be. And ISO 13485 certification is especially important in the context of medical app development – even more so with the Medical Device Regulation (MDR) becoming fully applicable in May 2021. If what you’re doing is related to healthcare, biotech, pharma, or digital health in general, you should definitely take this topic seriously. Read on to find out why ISO compliance is important in the medtech software development process.

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