The medical device development process is often broken down by experts into five distinct phases which all req...
The medical device development process is often broken down by experts into five distinct phases which all req...
The pursuit of quality in any company depends on your ability to transmit all kinds of organisational knowledg...
What should come first in a med tech project? Product development or documentation?
Companies working in heavily regulated sectors might have been historically slow to change and optimise their ...
Companies are often spurred to undertake business process mapping to improve their quality management.
How do you need your product management process to function? A classic article in the HBR got us thinking abou...
Good documentation practices (also known as GdocP or GDP) are standards for document management and control th...
As the 2020 deadline for compliance with the EU’s new Medical Device Regulation (MDR) fast approaches, the EC’...
The Good Automated Manufacturing Practice (GAMP 5 ®) guidelines define a set of core principles for GxP, as pr...