10 Benefits of Automating Medical Device Regulatory Compliance
With multiple complex regulatory compliance requirements, automation will be beneficial for managing regulatory compliance in medical device industry. By automating medical device regulatory compliance, companies will be placed in an advantageous position. Medical...
9 Key Differences Between Clinical Study and Clinical Evaluation of Medical Device
Clinical study and clinical evaluation of medical devices are common regulatory requirements for market approval. These terms are often used interchangeably. However, they have different purposes, are used in different situations, and have different protocols. Hence,...
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...