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FDA articles.

Every article in our archive in FDA.

FDA· Feb 16, 2026

From Idea to FDA Clearance: What Nobody Tells MedTech Founders

The biggest MedTech startup mistake isn’t the tech. Learn why clarity, FDA planning, quality systems, and cybersecurity determine success.

#FDA

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FDA· Feb 8, 2026

A New Era for Quality and Safety: What the FDA’s QMSR Means for Cybersecurity

FDA’s QMSR is now in effect. See why connected MedTech teams must build cybersecurity into the QMS - risk management, V&V, suppliers, and postmarket.

#FDA#Risk

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FDA· Dec 4, 2025

Cybersecurity Measures and Metrics for Medical Devices: Navigating FDA Compliance

Learn the difference between measures and metrics, FDA expectations, and how medical device makers use them to improve cybersecurity and protect patients.

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FDA· Nov 30, 2025

Navigating the FDA’s 18 Cybersecurity Deliverables for Medical Device Cybersecurity Submissions

Learn how to organize FDA medical device cybersecurity requirements into 18 key deliverables, from threat modeling and SBOMs to testing and labeling.

#FDA#Premarket

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FDA· Sep 29, 2025

Securing Medical Devices: The Key to Faster FDA Clearance and Investor Confidence

Proactive medical device cybersecurity drives faster FDA clearance, investor trust, and patient safety.

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FDA· Sep 16, 2025

The FDA’s New Medical Device Cybersecurity Rules Are More Than Red Tape

Manufacturers in any industry often seek regulations as barriers or obstacles. They may add costs to production or layers of oversight. Those are usually not palatable to business, but in medical device cybersecurity, these rules are much more than red tape. The Food & Drug Administration (FDA) rece

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FDA· Apr 13, 2025

Guide to Medical Device Cybersecurity Standards (Premarket, Postmarket, & Lifecycle)

Cybersecurity is no longer optional - it’s critical to patient safety and regulatory success. As medical devices increasingly connect to apps, cloud platforms, and hospital networks, manufacturers must follow stringent cybersecurity practices throughout the entire product lifecycle. At Blue Goat Cyber

#FDA#Premarket#Postmarket

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FDA· Apr 12, 2025

FDA Medical Device Submission Costs Explained: 510(k), PMA, and More (2025 Guide)

Navigating the FDA clearance process for medical devices involves more than technical documentation and testing - it involves significant regulatory costs that manufacturers must plan for early. Whether you're submitting a 510(k), Premarket Approval (PMA), or a De Novo request, understanding the latest

#FDA#510(k)#Premarket

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FDA· Apr 12, 2025

How to Navigate the FDA 510(k) and PMA Databases

Updated April 12, 2025 Understanding how to mine FDA databases for insights is a strategic advantage if you're bringing a medical device to market or managing one post-approval. These databases aren’t just regulatory archives. They're treasure troves of competitive intelligence, predicate data, and

#FDA#510(k)#Premarket

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FDA· Nov 17, 2024

V&V and Regression Testing for Medical Device Cybersecurity (FDA §524B)

How verification, validation, and regression testing work together to produce defensible FDA premarket cybersecurity evidence under Section 524B, IEC 62304, and the SPDF.

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FDA· Nov 13, 2024

RTOS Cybersecurity for FDA-Regulated Medical Devices

How to secure real-time operating systems (FreeRTOS, VxWorks, QNX, Zephyr) inside medical devices and evidence the controls in a §524B premarket cybersecurity submission.

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FDA· Nov 10, 2024

What is a Modular PMA Submission?

Discover the ins and outs of a Modular PMA Submission, a streamlined approach to gaining FDA clearance for medical devices.

#FDA#Premarket

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