An Overview of Working with the FDA

An Overview of Working with the FDA

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Breakout Session: Communicating with the FDA
Breakout Session: Communicating with the FDA
0 hr 37 min
FDA Advance Exclusive Webinar
FDA 510(k) Overview
FDA 510(k) Overview
Get to know this common FDA clearance path and understand when you'll need to use it.
0 hr 34 min
510(k) Initial QMS Procedures Product Development QMS Refinement & Regulatory Submissions Course
The Wait is Over: Assessing the Proposed Rule Aligning FDA's Medical Device Quality System Regulation with ISO 13485:2016
The Wait is Over: Assessing the Proposed Rule Aligning FDA's Medical Device Quality System Regulation with ISO 13485:2016
0 hr 40 min
ISO 13485 QMS FDA Regulatory Management QMS Refinement & Regulatory Submissions Advance Exclusive Webinar
The Definitive Guide to Responding to FDA 483 and Warning Letters
The Definitive Guide to Responding to FDA 483 and Warning Letters
This guide will go into great detail regarding exactly how to respond to FDA 483 observations and warning letters.
Initial QMS Procedures QMS Refinement & Regulatory Submissions Post-Market Surveillance Advance Exclusive eBook
A Step-By-Step Guide to Preparing your FDA 510(k) Submission
A Step-By-Step Guide to Preparing your FDA 510(k) Submission
Get ready to submit your 510(k) with advice from our industry experts
Document Management Design Controls Change Management Device Classification QMS 510(k) Product Development QMS Refinement & Regulatory Submissions Advance Exclusive eBook
Ultimate Guide to 21 CFR Part 820 - FDA's Quality System Regulation for Medical Devices
Ultimate Guide to 21 CFR Part 820 - FDA's Quality System Regulation for Medical Devices
Join Medical Device Guru Taylor Brown for a discussion on the requirements of 21 CFR Part 820 and why it might not be as challenging as it first seems to meet those requirements..
Risk Management Document Management CAPA Design Controls QMS Initial QMS Procedures Post-Market Surveillance Advance Exclusive eBook

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