What kind of sterilization methods can be used for a medical device?  There are different methods for the sterilization of medical devices, using gas and steam or radiation.   1. Radiation methods:   The principle of...

“A goal without a method is nonsense.” — W. Edwards Deming What is CDRH Validation? In the USA, the FDA’s Centre for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, re-label, and/or import medical devices sold in...

“It is thrifty to prepare today for the wants of tomorrow” — Aesop, Greek author (620 BC - 560 BC)  Validation costs are normally high and would be subject to more time and resources than a project without such requirements. However, there have...

US and Chinese legislation US legislation What is the framework of US Legislation? Figure 1: Framework of FDA Legislation. Adapted from FDA Legislation. Copyright 2020, Kvalito Consulting Group.   How to classify a device under US regulation? Picture from...