The Covid pandemic has brought new attention, investment and competition to the IVD sector. But with new oppor...
The Covid pandemic has brought new attention, investment and competition to the IVD sector. But with new oppor...
The EU In Vitro Diagnostics Regulation (IVDR), written in 2017, was developed to replace the existing EU In Vi...
Good Manufacturing Practices (GMP) are intended to ensure that pharmaceutical products, medical devices and ot...
Are you facing an urgent need to build a Quality Management System (QMS) for your medical device? Do you need ...
There’s plenty of document management and file-sharing software available on the market, but not all of it is ...
Having a repeatable procedure for Corrective and Preventive Action (CAPA) is a key FDA requirement for medical...
How does your organisation authorise, authenticate, document and police the use of electronic signatures withi...
If you want to develop a Quality Management System that meets the regulation and powers your commercial succes...
What are the planning requirements for a medical device design and development process? And what tools can hel...
