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510(k) Submission Checklist for Medical Devices: What to Include
A 510(k) shows your device is substantially equivalent to a cleared predicate. Use this checklist to build the submission in the order...
Oct 8, 20246 min read
FDA Warning Letters: What Every Medical Device Company Needs to Know
An FDA warning letter is a public notice that a company significantly violated medical device regulations. Common triggers include QMS...
Sep 20, 20244 min read
The Hidden Costs of Non-Compliance: How Medical Device Companies Can Avoid Regulatory Pitfalls
Non-compliance with FDA regulations can significantly damage medical device companies, both financially and operationally. In this...
Sep 12, 20245 min read
Maximizing Your Complizen AI Experience: How to Interact with AI for the Best Results
In today’s world, artificial intelligence (AI) plays a key role in making complex tasks easier and faster. For those in the medical...
Sep 9, 20245 min read
Why FDA Approval Is Important: Ensuring Safety, Efficacy, and Trust in Medical Devices
In the world of medical devices, FDA approval is more than just a regulatory hurdle—it's a crucial process that ensures the safety and...
Sep 4, 20243 min read
Understanding FDA Device Classifications: Class I, II, and III Explained
For medical device manufacturers, understanding FDA device classifications is crucial for successful product development and regulatory...
Aug 29, 20243 min read
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