Software Development Plan According to IEC 62304:2006
The development of software for SaMD (Software As Medical Device) and SiMD (Software In Medical Device) is regulated through a specific standard named IEC 62304 - Medical device software —
Vigilance Reporting Requirements according to EU MDR 2017/745
Introduction Vigilance reporting is one of the pillars of post-market surveillance process for medical device. It belongs to the so-called “passive” methods of post-market surveillance activities, as basically the manufacturer does
PRRC (Person Responsible for Regulatory Compliance) and the EU MDR.
The PRRC (Person Responsible for Regulatory Compliance) is one of the new requirement of the EU MDR European Medical Device Regulation and In-Vitro Diagnostic Regulation 2017/745 and 2017/746. The requirements
ISO 11167 : Requirements for Sterile Medical Device Packaging
ISO 11167 plays a fundamental role in the requirements related to packaging for sterile medical device. The design of packaging which is able to maintain sterility of the device through
Periodic Safety Update Report (PSUR) according to EU MDR 2017/745
One of the new requirement introduced with the EU MDR 2017/745 is the one related to the preparation of the Periodic Safety update Report (PSUR). This type of report is