Overview of the 510k Process
One of the most important regulatory submission processes for medical device manufacturers is the so-called 510k submission, used by FDA to authorize the introduction on the US market of medical
Device History Record (DHR): An Overview
The Device History Record (DHR) is a specific set of documentation requested by the FDA Quality System Regulation; however nowadays it is something that is typically requested by any type
Product Life Cycle for Medical Devices
The understanding and implementation of the regulatory requirements in the early stages of the product life cycle will ensure and adequate development of the medical product under development. The definition of
Design Transfer: A practical Approach
In the framework of the process of Design and Development, the design transfer (DT) corresponds to the last phase, where the specifications are basically transferred to the manufacturing environment to
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