Blog - QMS Software for Life Sciences

Life Science QMS (The Essential Guide)

For all industries, a Quality Management System (QMS) is essential to formalize the processes,...

The European Union In Vitro Diagnostic Regulation (EU IVDR) is the European law concerning placing...

Good Manufacturing Practices (GMP) is a part of the Quality Management System that helps ensure...

The benefits of a Quality Management System (QMS) are numerous and wide-ranging. A QMS will help...

The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single...

The ISO 15189:2022 is an international standard that specifies the requirements for quality and...

The ISO 13485:2016 is an international regulatory standard that specifies the requirements for...

To sell and market your medical device across the European Union (EU), you must have a CE marking...

Let’s imagine that your medical device company, headquartered in Nurnberg, Germany, has designed...

Imagine yourself in the shoes of a lead clinical investigator or a seasoned product manager...