ISO 24971 : A Practical Guideline to Risk Management Process
It is impossible to deny the importance of risk management process for medical device organization and the recent publication of…
21 CFR 803 : Medical Device Reporting according to FDA Regulation
The 21 CFR 803 is the section of the Code of federal Regulations which regulates the medical device reporting (MDR)…
Document Control Procedure
For any type of quality management system, whether within the medical device sector or not, having an established document control…
21 CFR 820 : Overview of the Main Requirements
The part of the Code of Federal regulation 21 CFR Part 820 is the section related to the requirements for…
The New IVDR Classification for In-Vitro Diagnostic Devices
One of the biggest changes introduced with the new IVDR 2017/746 is the classification for IVD products. In fact the…
The 10 Must-Have Contents for a Quality Plan
Quality Plan is an essential tool for many organisation to manage and handle specific quality projects in an extremely efficient…
Summary of Safety and Clinical Performance (SSCP) according to EU MDR
As we know, the European Medical Device Regulations introduced in new requirements for medical device manufacturers, especially in the field…
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…
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…
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…
