ALERT:
Last Day For Conference Discount

• OrthoTec: June 5-6
• MD&M East: June 17-20
• MD&M Texas: July 7-9
• MD&M Chicago: Sept 9-11
• MEDevice San Diego: Sept 26-27
• MD&M Minneapolis: October 28-30

Track A:
Design + Prototype

Learn how to disrupt innovation with Assumption Storming, acquire new skills from IDEO Creativity Workshop, design within Human Factors requirements, implement RoHS for materials selection, and more.

Track B:
Validation, Testing + Trials

Apply ISO 14971 successfully, learn new techniques from Risk Analysis Workshop, master the FDA guidance on Process Validation, understand biocompatibility testing, gain complete knowledge of clinical trials, and more.

Track C:
Regulatory Submission + Approval

Understand FDASIA and benefit-risk determinations, apply strategies for 510(k), PMA and Combo Products, implement UDI rule, learn tactics to bring medical devices to China, Japan and EU markets, and more.

Track D:
Post Market Compliance + Production

Master the art of complaints handling and MDR; learn how to respond to 483s, EIRs, warning letters, recalls; implement best practices in scale-up strategies and supplier management, and more.

Monday, Feb. 11
9 a.m.

Stanton J. Rowe,
Corporate VP & Chief Scientific Officer

Wed., Feb. 13
9 a.m.

Marc Madou,
Chancellor Professor & BioMEMS Lab Director

Thursday, Feb. 14
9 a.m.

David Gollaher
President & CEO

Jay Crowley,
Senior Advisor Patient Safety

Dan Solis,
Director of Import Operations, Los Angeles District Office

Ron Kaye,
Team Leader; Human Factors Pre-Market Evaluation Team, Office of Device Eval., Center for Devices & Radiological Health

Alonza Cruse,
Los Angeles District Director

Don St Pierre,
Deputy Dir. for New Product Evaluation, Office of In Vitro Diagnostic Device Evaluation & Safety

Randall Brockman,
Acting Chief Medical Officer, Office of Device Evaluation

View the Agenda

View the Speaker Line-Up