The 3 Types of 510(k) Submissions

The 3 Types of 510(k) Submissions

FDA - The 510k Program: Preparation of the 510(K) application and submission to FDA.Подробнее

FDA - The 510k Program: Preparation of the 510(K) application and submission to FDA.

How much does an FDA 510(k) submission cost?Подробнее

How much does an FDA 510(k) submission cost?

10 Steps to Preparing Your 510(k) Submission (and How to Avoid the Common Pitfalls)Подробнее

10 Steps to Preparing Your 510(k) Submission (and How to Avoid the Common Pitfalls)

Regulatory Compliance through 510(k) Application: Basic Guide for U.S. Medical Device Market EntryПодробнее

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Webinar: Medical Devices Cybersecurity in 510(k) Premarket SubmissionsПодробнее

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The “New” 510(k): How Do You Show Substantial Equivalence without Using a Predicate?Подробнее

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How to Prepare a Medical Device 510k Submission for FDAПодробнее

How to Prepare a Medical Device 510k Submission for FDA

Guidance on Device Changes: When to Submit a 510(k)Подробнее

Guidance on Device Changes: When to Submit a 510(k)

510(k) Tip - Don't worry about classification when you're trying to determine the regulatory pathwayПодробнее

510(k) Tip - Don't worry about classification when you're trying to determine the regulatory pathway

What is the difference between a 510k and De Novo?Подробнее

What is the difference between a 510k and De Novo?

510(k) Project Management Best PracticesПодробнее

510(k) Project Management Best Practices

510(k) Tips and TricksПодробнее

510(k) Tips and Tricks

De Novo vs 510k - What’s the differenceПодробнее

De Novo vs 510k - What’s the difference

How long does a 510(k) submission take to get cleared?Подробнее

How long does a 510(k) submission take to get cleared?

Nanox -- FDA update -- On The Right Path?Подробнее

Nanox -- FDA update -- On The Right Path?

510(k) eSTAR Webinar - Indications for Use and ClassificationПодробнее

510(k) eSTAR Webinar - Indications for Use and Classification

Three 510(k) tipsПодробнее

Three 510(k) tips

Mastering your 510(k) submission processПодробнее

Mastering your 510(k) submission process

FDA eSTAR - General Info - #1 in the 510(k) eSTAR seriesПодробнее

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