Recent/Current Projects:
Upper GI trans-oral / Endoluminal projects
Left atrial appendage occlusion projects
2005 – Pres. – Daniel & Daniel Consulting
FDA 510k / Canadian / European CE Mark Approvals
SonoSite Inc – Handheld Ultrasound
EndoGastric Solutions – Trans-Oral, GERD and Obesity Devices
LAAX Inc. – Le Atrial Appendage Occlusion Devices
2006 – Pres. – Director Regulatory A airs for EndoGastric Solutions
Responsible for FDA and OUS product submissions and clearance
2005 – 2006 – Director Quality Assurance for EndoGastric Solutions
Responsible for development of quality system, CE Mark, ISO 13485:2003 certifi cation and FDA QSR compliance
1998 – 2005 – Director Quality Assurance – SonoSite Inc.
Responsibilities included development of ISO/FDA compliant quality
system. Received ISO certi cation and CE Mark.
Also held various management positions through start-up of company
including management of product & supplier quality; operations management;
manufacturing engineering management and business systems management.
