Companies commonly face the challenge of assessing and updating design history files (DHF) as a result of design obsolesce, product updates, transfer of design ownership and changing regulatory requirements. This seminar will provide an overview of DHF requirements, presents a framework for DHF gap analysis and remediation, and offer a checklist of critical DHF assessment areas for complex medical devices.
Thursday, December 7 - at UEL -- 1000 Westgate Drive St Paul 55114
2nd Floor Conference Room (courtesy of MN Lions Eye Bank)
7:30 a.m. Registration & Networking Breakfast, with program 8 - 9:30 a.m.
$45 per person -- FREE for UEL Tenants
REGISTER HERE TODAY!
Guest Speaker - John R. Ballard, Ph.D.
John has more than 12 year experience in research and product development experience in the medical device field. He has extensive experience in ultrasound imaging, therapeutic ultrasound, and signal processing algorithm development. John has worked on an array of medical device products including: medical imaging products, surgical devices, cardiac monitoring equipment, and in vitro diagnostic systems. Prior to joining Design Solutions, Dr. Ballard was a Senior Innovation Fellow at the Medical Device Center at the University of Minnesota and co-founder of Andarta Medical, a start-up from research work developed at the Medical Device Center. John has a BSEE degree from Michigan State University, a MSEE degree from the University of Minnesota and a PhD in Electrical Engineering from the University of Minnesota.