Introduction “If you cannot measure it, you can’t improve it.” — Peter Drucker First Established in 805 CE in...
Introduction “If you cannot measure it, you can’t improve it.” — Peter Drucker First Established in 805 CE in...
Table of Contents The German Supply Chain Due Diligence Act (SCDDA) at a Glance Due Diligence Legal Framework for a...
Table of Contents Ancillary or Raw Materials AM qualification Emerging Technologies Conclusion Regulations References...
"Proper documentation is the only witness of what you have done: in its absence, you did nothing; if it is poor, you...
Development and Validation of Digital Pathology Digital pathology means the use of technology to accelerate and...
“Discovering the unexpected is more important than confirming the known.” —George Box, Stuart Hunter, and William G....
"Change before you have to." —Jack Welch A Laboratory Information Management System (LIMS) is software that allows...
What kind of sterilization methods can be used for a medical device? There are different methods...
“A goal without a method is nonsense.” — W. Edwards Deming What is CDRH Validation? In the USA, the FDA’s Centre for...
“It is thrifty to prepare today for the wants of tomorrow” — Aesop, Greek author (620 BC - 560 BC) Validation...
US and Chinese legislation US legislation What is the framework of US Legislation? Figure 1: Framework of FDA...
What types of risks are covered by Risk management? It covers the harms related to patients, users or/and environment....