Documentation, Medical Devices, and the FDA

This month the implementation date for MDD directive (2007/47/EC) comes due. There are a number of issues that require action by manufacturers (changes to the Essential Requirements, clearer requirements for clinical evaluation, changes to the QA of third parties) and...

The Benefit Content Reuse Brings to Business

Their reuse is at 90%. Their writers are reusing written, translated, validated translations that they can prove are untouched and reused as is. In their system, they can certify, based on the validity of the system, that they are using exactly the same content. They haven’t touched it; there are no changes: they haven’t created a revision that triggers other processes and other costs.