Why People are Talking About the Medical Device Quality Congress…

“As a repeat attendee, I highly recommend this conference. The workshops, interactive sessions and insights from reputable speakers are very useful and applicable information to take back and share with my company and colleagues.”
Heather Jalisi, Quality Assurance Manager, DexCom Inc.

“I would recommend the seminar in view of strengths of topics discussed and speakers who are well respected in industry.”
Remy Estera, Team Leader, Quality Assurance in Manufacturing, Resmed Ltd. Australia

“It was extremely refreshing to attend a conference with the focus on Medical Devices. Too often with conferences the focus is on drugs. This conference was very well done!”
Joseph Sondej, Associate Manager Quality Control, Celgene Cellular Therapeutics

“One of the most beneficial Congress’ I have ever attended.”
Alejandro Lamas, Quality Assurance Manager, Medtronic Mexico

“Compilation of insightful presentations, covering issues faced by every device manufacturer, presented by industry leaders.”
Chris Lake, Manager Quality Assurance and Regulatory Affairs, Epimed International

Valuable guidance for building effective quality systems, including:

What to expect from FDA and worldwide regulatory bodies with regard to managing patient risk
Common pitfalls inherent with many risk management programs
Implement a complete life cycle approach to ISO 14971 and ISO 13485 and gain internal value
Understand FDA enforcement actions including warning letters and certificates to foreign governments
Comprehend what happens when the FDA sues: 1) the “sign or sue” letter; 2) settlement options; 3) consent decree/disgorgement
Grasp the Federal Rules of Civil Procedures in litigation
Medical Device Reporting Requirements: understand what is and isn’t reportable and why
Hear examples of effective medical device reporting activities
How to avoid pitfalls in decision making criteria for what to report
Methods to achieve compliance with the design control requirements of the QSR
How to document design changes
Understand design inputs and outputs – what to include and not to include
Realize and communication how QSR affects corporate strategy