Methodologies for Training Effectiveness
Training effectiveness is one of the key requirements associated to Quality Management System according to ISO 13485. Having adequate methodologies for delivery of training and evaluate effectiveness of this training
Design and Development Plan
In this article, we want to give you a deep dive into the requirements associated to the Design and Development Plan. As you know, the Design Process for medical devices
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 linked with the safety of the devices on the field
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 the updated version of ISO 24971 is a valuable tool
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) according to FDA regulation. We have been trough the
