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Post-Market Surveillance for Medical Devices: Ensuring Ongoing FDA Compliance
FDA postmarket surveillance means monitoring safety, investigating complaints, filing MDRs within 30 days (or 5-day in certain cases) ,...
Oct 31, 20244 min read
FDA Guide to AI/ML SaMD: Pathways, PCCP, and Evidence
FDA regulates AI and ML in SaMD using existing device pathways plus AI-specific expectations. Key elements include the 2025 PCCP Â final...
Oct 29, 20245 min read
FDA's Software as a Medical Device (SaMD) Explained
As technology continues to transform healthcare, Software as a Medical Device (SaMD) Â has become crucial in diagnostics, treatment, and...
Oct 25, 20245 min read
Beginner’s Guide to FDA Compliance for Medical Devices
FDA regulates medical devices from classification through postmarket monitoring. This beginner’s guide shows how to determine class and...
Oct 22, 20246 min read
How to Respond to an FDA Warning Letter: Step-by-Step Guide
An FDA warning letter is a public notice of significant violations that requires a written response within 15 working days. This...
Oct 17, 20246 min read
How to Choose the Right Predicate Device for Your 510(k) Submission
When it comes to FDA submissions , selecting the right predicate device  for your 510(k) submission  is one of the most critical steps....
Oct 15, 20246 min read
Top 10 FDA Medical Device Regulatory Mistakes and How to Avoid Them
Navigating FDA regulations  can feel like walking through a maze. One wrong turn, and your medical device’s path to market  could face...
Oct 9, 20245 min read
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
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
Can FDA Approval Be Revoked? A Comprehensive Guide for Medical Device Companies
TL;DR: Revocations are rare . FDA far more often uses recalls , warning letters , or temporary suspensions to correct problems before...
Aug 8, 20245 min read
How to Get FDA Approval: A Step-by-Step Guide for Medical Device Companies
For medical device manufacturers, obtaining FDA approval is a critical milestone in bringing innovative products to market. This...
Aug 2, 20243 min read
How FDA Approval Works: A Comprehensive Guide for Beginners
If you're new to the medical device industry or considering bringing a medical device to market, understanding the FDA approval process...
Jul 25, 20246 min read
How Long Can FDA Approval Take?
For medical device manufacturers, bringing a new product to market involves navigating the complex landscape of regulatory compliance....
Jul 16, 20244 min read
How AI is Transforming Regulatory Compliance
Navigating the complex waters of regulatory compliance has long been a challenge for businesses across the globe. As the volume and...
Jul 3, 20245 min read
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