Two-Day Workshop: Preparing Premarket Submissions That Secure U.S. FDA Clearances/Approvals 510(k) Pre-IDE/IDE and PMA (Morrisville, NC, United States - April 27-28, 2017) - Research and Markets

DUBLIN--()--Research and Markets has announced the addition of the "Preparing Premarket Submissions That Secure U.S. FDA Clearances/Approvals 510(k) Pre-IDE/IDE and PMA" conference to their offering.

This workshop-style training course is designed based on 30 years of regulatory affairs experience in preparing more than 150 successful U.S. FDA submissions for major medical device companies.

In these 2 days, the following essential elements of U.S. FDA premarket submissions will be covered:

- History and Background of U.S. FDA Laws and Regulations

- Classify Your Device

- Choose the Correct Premarket Submission for Your Device

- Compile the Appropriate Information for Your Premarket Submission

- Author and Prepare Your Premarket Submission

- Submit Your Premarket Submission to the FDA

- Interact with FDA Staff During Review and Approval

- Complete the Establishment Registration and Device Listing

Who Should Attend:

- Regulatory Affairs Professionals (associates, specialists and managers)

- Marketing Professionals

- Research & Development - Product Managers

- Quality Assurance and Quality Engineers

- Project Managers Responsible for United States

- Buyers/Purchasing Professionals

- Students majoring in Regulatory Affairs

Agenda:

Day 1 Schedule

Lecture 1: An Overview of U.S. FDA Premarket Regulations

Lecture 2: Premarket Notification 510(k)

Lecture 3: Premarket Notification 510(k) - Continued

Lecture 4: Premarket Notification 510(k) - Continued

Day 2 Schedule

Lecture 1: Premarket Approval (PMA)

Lecture 2: Premarket Approval (PMA) - Continued

Lecture 3: Investigational Device Exemption (IDE)

Lecture 4: Post-Market Requirements for Medical Devices

For more information about this conference visit http://www.researchandmarkets.com/research/ztlmsw/preparing.

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For EST Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Medical Devices

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For EST Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Medical Devices