When

Saturday, October 7, 2017 from 8:00 AM to 5:00 PM PDT
Add to Calendar

Where

International Technological University

2711 N 1st St

San Jose, CA 95134

Azadeh Adibi
Course Coordinator
ASQ Silicon Valley - Section 0613
course-coordinator@asq-silicon-valley.org|

408-806-2305

Suzanne Geiss

Susie Geiss
Education Committee Chair
ASQ Silicon Valley - Section 0613
asqedu@gmail.com

831.239.2016

Contacts

Azadeh Adibi
Course Coordinator
ASQ Silicon Valley - Section 0613
course-coordinator@asq-silicon-valley.org|

408-806-2305

Suzanne Geiss

Susie Geiss
Education Committee Chair
ASQ Silicon Valley - Section 0613
asqedu@gmail.com

831.239.2016

B113 - Preparing & Submitting 510K's & PMA's

Overview

US Regulation history and overview
Medical Device Users Fee and Modernization Act (MDUFMA)
Medical Device Classification
Key terms and elements
FDA regulatory pathways
When 510(k) is required
Types of 510(k)s
Planning and executing a 510(k)
The FDA 510(k) review process
When to submit a 510(k) for a changed device
When a PMA is required
Types of PMAs
Planning and executing a PMA
Points to consider
The FDA PMA review process
PMA Supplements
Other worldwide regulatory bodies and authority
Regulatory compliance issues overviewo

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Benefits

This course covers materials that are essential to those individuals who are interested in medical device submissions to the FDA and presents an overview of regulatory pathways for medical devices in the U.S. with a focus on the FDA 510(k) process including IDE, PMA, HDE, de novo 510(k), combination products, and CE Marks.

Instructor Patrick Lee

Instructor Bio

Patrick Lee, PE, RAC is currently the Director of Regulatory Affairs at ThermoGenesis Corp. Previously, Patrick worked at Solta Medical, Micrus Endovascular, and other medical device companies . Patrick has managed regulatory submissions for US, EU, Canada, Australia, Latin America, and Asia and has received marketing approvals worldwide. Patrick has experience in developing interventional neuroradiological devices, aesthetic devices, drug-delivery devices, stem-cell devices and products, and in working in other FDA-regulated industries. Patrick received his BS in Chemical Engineering from Cornell, MS from Columbia, and his MBA from the Anderson School at UCLA. He is a licensed Professional Engineer in the states of New Jersey and California and holds several patents. Patrick holds the US Regulatory Affairs RAC (US) designation.

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Course Times

8:00 a.m - 5:00 p.m.

Lunch Break: 12:00 - 1:00 p.m.

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Course Details

Prerequisites: Participants are expected to be familiar with basic design controls and risk management for medical devices

Hardware: N/A | Software: N/A

Required Materials:

- Proof of online Payment

- Pencil & Paper or laptop/tablet if you prefer

- If you are an ASQ member, a current-dated ASQ Membership ID

- Valid ID(s): sites may require US citizens to provide a Driver's License or a State-Issued ID; if you are not a US citizen you must bring 2 valid forms of identification

Learning Method: Lectures, teams, case studies, hands on approach, class discussions and examples

Class Time: 8 hours

Class Size: 25 max. participants

Facilities: Room with PC projector, whiteboard, etc.

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