Building a quality management system is never a quick and simple process. But in medical device development, w...
Building a quality management system is never a quick and simple process. But in medical device development, w...
Following Britain’s exit from the EU, all non-UK medical device and IVD manufacturers who want to place their ...
IVD device regulation is about upping the bar—it’s about making products to a higher standard and ensuring t...
ISO 9001:2015 and its related quality standards are all based on the ‘Seven Quality Management Principles’ def...
Supplier management needs to be a collaborative and proactive process if it’s going to deepen key relationship...
Document control is a key part of any Quality Management System (QMS) and, therefore, a requirement of ISO 900...
The medical device development process is typically broken down into five distinct phases. Each one requi...
A document management system (DMS) is a method of managing, storing and retrieving all the documentation a bus...
How much control do you have over the documents your business generates? How much do you need?
