B114 - CE Marking & Other EU/International Regulations

Overview

This course will cover all aspects of CE Marking Requirements with an emphasis on medical device regulations for the EU

Quality System Requirements- ISO 13485/MDD
ISO 13485:2003
Risk Management- ISO 14971
The EC Directive process and CE marking• Background of the new approach directives
The role of notified bodies and competent authorities
MDD Requirements
MDD Updates/Revisions/Current Status
Conformity Assessment Options
Technical files
Design Dossiers
Type Exams
Format Control
All Aspects of Reporting
Vigilance requirements and case studies
General Requirements
Design Requirements
Labeling
Clinical Data
Common issues
Examination
Wrap up/Review Exam

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Instructor Patrick Lee

Instructor Bio

Patrick Lee, PE, RAC, CQA is currently the Director of Regulatory Affairs at Iridex Corp. Previously, Patrick has worked at Cesca Therapeutics, ThermoGenesis, Solta Medical, Micrus Endovascular, and other medical device companies . Patrick has managed regulatory submissions and compliance in 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 and CQA from ASQ

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Course Times

8:00 a.m - 12:00 p.m.

This is a 4 hour class.

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Course Details

Prerequisites: None

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: 4 hours

Class Size: 25 max. participants

Facilities: Room with PC projector, whiteboard, etc.

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