BRC Risk Analysis

BRC risk analysis is about the guidelines issued by the international risk analysis body, the British Retail Consortium (BRC). Being a product of deliberations over a long period of time; BRC is today a global food safety standards body thatis hard onrisk analysis. This makes BRC risk analysisa unique proposition that stands apart from its […]

Analytical method transfer

Analytical method transfer is an important element of a laboratory. A laboratory will be required to send or transfer its methods for a variety of reasons to another laboratory. During this process, analytical method transfer comes into play. Analytical method transfer has been described as“…the process of transferring a validated analytical method from a sending […]

Analytical method transfer guidelines from FDA

Theoretically speaking, analytical method transfer guidelines from FDA are quite simple. The logic behind analytical method transfer guidelines from FDA is like this: in its elementary form, analytical method transfer is the way by which a laboratory becomes qualified to use a test procedure. In setting out analytical method transfer guidelines, FDA makes it mandatory and necessary […]

Risk Management in IEC 60601-1 Third Edition

Risk Management in IEC 60601-1 Third Edition Risk Management is a critical factor in IEC 60601-1 Third Edition. This is one of the important additions that have been made to this edition from the previous one. The new legislation requires that Risk Management be implemented in the product lifecycle throughout the standard. Risk Management at […]

: In vitro diagnostics are performed outside the living organism in a controlled environment

Description: These are medical devices and other accessories that are used to perform tests on samples that are extracted from the living organisms Understanding In-Vitro Diagnostics In vitro diagnostics: Introduction The word ‘invitro’ means ‘in glass’ in Latin. In vitro diagnostics are performed outside the living organism in a controlled environment, generally in a test […]