The 3 Types of 510(k) Submissions

The 3 Types of 510(k) Submissions

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)

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

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

How to Prepare a Medical Device 510k Submission for FDAПодробнее

How to Prepare a Medical Device 510k Submission for FDA

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

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

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

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

510(k) Tips and TricksПодробнее

510(k) Tips and Tricks

Three 510(k) tipsПодробнее

Three 510(k) tips

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

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

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

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

510(k) Project Management Best PracticesПодробнее

510(k) Project Management Best Practices

Using the new eSTAR templates for a 510(k) submission and the FDA eSTAR draft guidanceПодробнее

Using the new eSTAR templates for a 510(k) submission and the FDA eSTAR draft guidance

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

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

Learn how to avoid receiving an RTA Hold letter when you submit your 510(k) submission to the FDA?Подробнее

Learn how to avoid receiving an RTA Hold letter when you submit your 510(k) submission to the FDA?

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

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

NANOX ARC 510K Submision -- What Happens Now? (NNOX Stock)Подробнее

NANOX ARC 510K Submision -- What Happens Now? (NNOX Stock)

De Novo vs 510k - What’s the differenceПодробнее

De Novo vs 510k - What’s the difference

Mastering your 510(k) submission processПодробнее

Mastering your 510(k) submission process

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

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

What Are The 3 Types of FDA Pre-Market Submissions? By Proxima CROПодробнее

What Are The 3 Types of FDA Pre-Market Submissions? By Proxima CRO