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

  • All

  • Process & Management

  • Medical Regulations

  • Medical Software Know-How

  • Healthcare News & Info

Search results for: 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.

Read article

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.

Read article

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.

Read article