NIS2 and the Challenge of Turning Risk into Opportunity
You wouldn’t believe how many times, when trying to conduct a Risk Analysis in an organization, we’ve heard things like: “If we only think about the bad stuff, we’ll never get anything done,”
Is your CCRA aligned with the realities of your plant?
It has now been 10 years since the last revision of Chapters 3 and 5 of the GMP Guidelines came into force.
Everything You Need to Know About the 510(k) Process
Navigating FDA requirements can be complex, and the 510(k) process is no exception. If you’re developing a medical device for the U.S.
Qloud Qualificates: The New Digital Qualification Service
The pharmaceutical industry is constantly evolving, and digitizing critical processes such as equipment qualification is key to improving efficiency, safety, and regulatory compliance.
FDA Medical Device Registration: Pathways to Market Approval
Navigating the FDA registration process can be complex, but choosing the right pathway is key to bringing your medical device to market successfully.
Medical Device Registration with the FDA: Key steps and requirements
The registration of medical products with the United States Food and Drug Administration (FDA) is a crucial step for companies seeking to market their products in one of th…
Challenges of Initial Qualification of Thermal Equipment Using Traditional Methods
The initial qualification of thermal equipment is a fundamental step in ensuring compliance with regulations and safety in industries such as pharmaceuticals, food processi…