Correction, Corrective Action, and Preventive Action (CAPA): Scope & Differences
Having a robust correction, corrective action, and preventive action system will help ensure regulatory compliance. Hence, most regulatory guidelines recommend implementation of a CAPA system. Our blog post on correction vs corrective action vs preventive action will...
6 Differences Between US FDA De Novo and FDA 510(k) Pathways
The US FDA offers multiple regulatory pathways for medical devices entering its market. In this blog, we have highlighted the differences between US FDA De Novo and FDA 510(k) pathways. FDA De Novo and FDA 510(k) To understand the differences between FDA De Novo and...
5 Step Guide to Manufacturing Dental Cement: Global Regulations
Dental cements are materials used in dentistry to bond restorations, fill cavities or act as liners, and provide temporary/permanent adhesion. Hence, they have a crucial role in modern dentistry. As dental cements are of pivotal importance in dentistry and are...