B2DG- Managing complaints,adverse events, and recalls, Connie Hoy, VP RA/QA, Xoft Inc.

Bio2Device Group
October 7, 2008

Managing complaints,adverse events, and recalls

Connie Hoy
Vice President of RA/QA
Xoft, Inc.

This presentation will review the various actions that may be
taken by a medical device manufacturer when it is determined
that there is a health risk to the public that requires
action. One challenge is how to decide when a recall or
correction / removal is warranted. We will review some
specific case studies that reflect the FDA perspective on
this. Once the decision for a recall is made, specific
documentation must be generated and timelines must be met. We
will then discuss what these actions are as well as how to
interface with the FDA and what can be expected by the FDA.
The relationship between incidents in the US and outside the US
will then be covered to add clarity on what is appropriate.
Finally, Connie will discuss how to minimize the impact of a
recall on your business.

Connie Hoy joined Xoft, Inc as VP RA / QA in December, 2007.
Prior to that she spent over 12 years working in the medical
laser industry, most recently as VP RA/ QA at Cutera, Inc and
prior to that VP RA / QA at Lumenis, Inc.

Connie began her career 22 years ago at a start-up company that
developed sterile implantable devices. During her 8 years at
Oco Biomedical, she served as the President of the Dental
Implant Manufacturer's Association and the Southwest Biomedical
Coalition. In 1995 she joined Tissue Technologies as the
Director of Regulatory Affairs, where she led the effort to
become one of the first ISO 9001 / EN 46001 certified medical
companies in the US. When Tissue Technologies was acquired by
Palomar Medical, Connie served as a transition team member and
subsequently worked for Palomar as the team leader for ISO
implementation at the Palomar home office and for their
subsidiaries located in Auburn, CA and Pleasanton, CA. Connie
was also an industry representative on the advisory board that
consulted with FDA on the implementation of the 1996 revision
of the Quality System Regulations.

Connie then joined Cell Robotic, Inc where she obtained the
first 510(K) clearance for a medical laser device to be sold
into the home. The device was used for obtaining capillary
blood samples for diabetes testing. This led to a move from
Albuquerque, NM to Woodland, CA where she continued her career
in the laser industry.