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...
I worked in one of the large Cambridge-based technology consultancies for many years and was privileged to hav...
Are you facing an urgent need to build a Quality Management System (QMS) for your medical device? Do you need ...
I believe that a quality strategy is a vital element to the success of a business. Quality of product and op...
There’s plenty of document management and file-sharing software available on the market, but not all of it is ...
Mention ISO 9001 to most people, or tell them that you implement quality systems, and they'll start glazing ov...
Having a repeatable procedure for Corrective and Preventive Action (CAPA) is a key FDA requirement for medical...
