Lipstick is a staple cosmetic product. The demand for imported lipstick in India is on a steep rise. Increase in disposable incomes, influence of beauty trends driven by social media, and expanding e-commerce footprint are driving the growth. Furthermore, a...
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...
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,...
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...
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...