The biocompatibility of Medical Devices is the ability of a device to interact with the human body without causing unacceptable biological [...]
EUDAMED is the European Union's online database for Medical Devices. It serves as a centralized system where: Manufacturers register their [...]
Translated with A.I. For Medical Devices and in vitro diagnostic Medical Devices, cybersecurity is essential to satisfy the General Safety [...]
The new Quality Management System Regulation (QMSR) comes into effect on February 2, 2026, following the publication of the Final Rule [...]
According to MDR (EU) Regulation 2017/745, IVDR (EU) 2017/746 and ISO 20417, printed matter comprises all information provided by the manufacturer [...]
Post-market surveillance (PMS) of Medical Devices in Great Britain plays a key role in ensuring user safety and compliance. With the [...]
The in vitro diagnostic medical device (IVD) industry is going through a challenging transition phase, marked by the IVDR Regulation [...]
Periodic Safety Update Reports (PMS Reports) and Periodic Safety Update Reports (PSURs) play a central role in the management of Post-Market [...]
The European Union's MDR (EU) 2017/745 requires medical device manufacturers to adopt a systematic Post-Market Surveillance (PMS) process to ensure the [...]
Change management in Medical Devices is essential to ensure European and international compliance. After the product is first placed on the [...]
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