Can you ever make a stage-gate process Agile? Can modern tools and a hybrid approach to Waterfall and Agile br...
Can you ever make a stage-gate process Agile? Can modern tools and a hybrid approach to Waterfall and Agile br...
Not all business management software solutions are created equal. They come in different shapes and sizes, wit...
Time and costs can soon rack up in a med tech device design and development cycle. But those who have installe...
Issuing a tech product release or a software update can be a challenging process. Handled badly it can result ...
I am a former FDA staff member and now back in the private sector. If you are in Regulatory Affairs, you are i...
From 2022 the In Vitro Diagnostics Regulation (IVDR) will require Notified Body intervention and review for 80...
ISO 9001 and its related quality standards are all based on the ‘Seven Quality Management Principles’ defined ...
Google Drive and Dropbox are two of the most popular cloud-based, file-sharing platforms on the market today. ...
From 2020 and 2022, EU Medical Device Regulations will change. This brings certain products into regulatory sc...
