Difference Between CE mark and FDA Approval: Detailed Guide
In this blog, we have highlighted the key differences between CE mark and FDA approval. Additionally, we have discussed which is easier to secure and the required timelines for approval. This blog will be especially helpful for those entering new international...
US FDA Regulatory Pathways for New Medical Devices
US FDA has stringent regulations for medical devices entering the US market. For launching a new medical device in US, you need to mandatorily comply with all FDA medical device regulatory guidelines. Additionally, you need to secure the applicable approval type for...
What is the difference between US FDA 510(k) and PMA? A Guide
All medical devices entering the US market must comply with the regulatory requirements formulated by US FDA. These regulatory requirements are in place to ensure safe, effective, and high-quality medical devices reach the patients. The regulatory pathway required...