Saturday, November 11, 2017 from 8:00 AM to 5:00 PM PST
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International Technological University (ITU) 

2711 North First Street

San Jose, CA 95134




Azadeh Adibi
Course Coordinator 
ASQ Silicon Valley - Section 0613 


Suzanne Geiss

Susie Geiss
Education  Chair
ASQ Silicon Valley - Section 0613 




B114 - CE Marking & Other EU/International Regulations 

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

Instructor Patrick Lee

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


Course Times

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

This is a 4 hour class.


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.