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…
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…
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…
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…
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)…
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…
Device Master Record
The device master record is a design document specifically requested by the FDA Quality System Regulation, as per 21 CFR…
FDA Requirements for UDI on Medical Devices
The UDI (Unique Device Identification) is a system used to uniquely identify medical device sold in a specific country, for…
FDA Labelling Requirements: An Overview
FDA labelling Requirements
ISO 62366 and Usability Requirements for Medical Device
ISO 62366 plays a fundamental role in the design process for medical device as it explains the requirements related to…