ISO 13485 Audit Checklist
Internal audits are one of the most important process within a Quality Management System for Medical Device manufacturers and having…
Methodologies for Training Effectiveness
Training effectiveness is one of the key requirements associated to Quality Management System according to ISO 13485. Having adequate methodologies…
Design and Development Plan
In this article, we want to give you a deep dive into the requirements associated to the Design and Development…
Complaint Handling Process for Medical Device Manufacturers
The complaint handling process for medical device manufacturers is of fundamental importance for multiple reasons. Surely, compliant process is directly…
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…
