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LIMS Implementation: Success Factors from a Project Manager Perspective

"Change before you have to." —Jack Welch A Laboratory Information Management System (LIMS) is software that allows your laboratory to manage samples and associated data effectively. Its primary purpose is to improve lab efficiency and accuracy by reducing manual...

Sterilization Processes for Medical Devices

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...

CDRH Validation vs. CSV

“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...

How to Overcome Validation Costs

“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...

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