SaMD

The Digitalization of Quality Management Systems

The Digitalization of Quality Management Systems

One blessing that occurred in the recent years is the rapid digitalization of business functions. It’s hard to imagine a time before the use of video calling or instant messaging to reach teammates or clients from across the world almost immediately.

HIPAA and GDPR’s impact on Medical Devices

HIPAA and GDPR’s impact on Medical Devices

The European Union’s General Data Protection Regulation (GDPR), which was put into effect on May 25, 2018, is often considered to be one of world’s toughest laws when it comes to privacy and security. The regulations lay down privacy and security standards, imposing obligations on any/ all organizations having an impact on the people of EU, whether related to targeting or collecting data.

Software as a Medical Device

Software as a Medical Device

Software-related medical devices are taking over the medical device industry. There are three types of software-related medical devices in the industry software as medical devices, the software is integral to medical devices, and software used in the manufacturer or maintenance of a medical device1. Software that is….

Regulating Software

Regulating Software

‌  Medical devices have advanced beyond the point of simple machinery. Software has begun playing an important...

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