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

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

What is Quality Management Systems (QMS)?

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

What is Software in a Medical Device (SiMD)?

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

What is Software as a Medical Device (SaMD)?

• Medical Device Regulation (MDR),

What is Notified Body?

• Medical Device Regulation (MDR),

What is Medical Device Directive (MDD)?

• Medical Device Regulation (MDR),

What is Medical Device Regulation (MDR)?

• Medical Device Regulation (MDR),
• Data Security,
• ISO 13484 (medical devices),

Security of data documentation – electronic health records and patient data

One of the most critical issues concerning the computerization of the healthcare system is data documentation security. The obligation to ensure both physical and electronic health records (EHR) and other types of healthcare data is largely on the medical institutions. In the following text, we’ll look at the conditions they must meet under the law and good practices. We’ll also present the life cycle of documents and suggest what standards should be completed by a software provider if you’re to entrust them with the digitization of your medical facility data.

• Data Security,
• Medical Device Regulation (MDR),

Technical & legislative challenges of cloud solutions for healthcare software

The eHealth industry’s growing at a breakneck pace, undoubtedly influenced by the ongoing COVID-19 pandemic and technological advancements, including the use of cloud solutions for healthcare. According to a report compiled by Market Data Forecast, this market is currently valued at $14.8 billion and is expected to grow to $29.5 billion by 2026. This implies a CARG (Compound Annual Growth Rate) of 14.8% for the eHealth sector over the forecast period. What impact do cloud solutions have and will have on the growth of the eHealth sector? What technical and legal challenges connected to using the cloud are there in the healthcare market? Let’s try to answer these questions.

• 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 working on improving people’s lives through technology. But it also means having to adhere 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. Let’s dive into why it exists, what it means for the healthtech sector, and why you should get familiar with it – especially if you’re planning to launch your medical app in Europe.