510(k) Project Management Best Practices

510(k) Tip - Project Management is essential to 510(k) successПодробнее

Traceability Matrix Webinar for 510(k) Software DocumentationПодробнее

510(k) Project Management - Updated for 2021Подробнее

Communication Best Practices – Interacting with Regulatory Project Managers in CDER/OROПодробнее

How to prepare an FDA eSTAR 510(k) submissionПодробнее

FDA guidance for the content of human factors in medical device 510k submissionsПодробнее

Cybersecurity Documentation for a 510(k) SubmissionПодробнее

Mastering your 510(k) submission processПодробнее

510(k) Tips and TricksПодробнее

The 3 Types of 510(k) SubmissionsПодробнее

Choosing the Best FDA Submission Pathway for your ProductПодробнее

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

How to Prepare a Medical Device 510k Submission for FDA | Rob Packard | Joe HageПодробнее

How Long Does a 510(k) Actually Take?Подробнее

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

Basics of 510(k) Clearance ProcessПодробнее

My Jobs Before I was a Project ManagerПодробнее

510(k) Pre-Submission Webinar - Stop Wasting Time and Request a Pre-Sub MeetingПодробнее