Software, Design Control, and Medical Devices (July ASQ Biomedical NCDG Roundtable)
Wednesday, July 23, 2014 from 7:00 PM to 9:00 PM (PDT)
Join ASQ NCDG in the our Design Control Series Roundtables ....this round table focuses on Software, Design Control, & Medical Devices:
Continuing the series of Roundtables on Design Control, this program will focus on what design control means to software. This program will cover when design control applies to software, when it doesn’t and to what types of software. Each design control step will be reviewed with respect to software, along with the documentation expected for each step. Additional emphasis will be placed on software requirements (Design Input) and on software verification and validation. As this program has been preceded by questionnaires at other programs, there will be an extended question and answer session. Note that this program is focused on design control and software so while IEC 62304 is not ignored, neither is it a significant aspect of the program.
Discussion, topics, and examples from the audience are encouraged.
Featured Speaker: Carol W. Curran
Carol W. Curran is the President and primary consultant for Curran Consulting LLC. Curran Consulting LLC is focused primarily on the software aspects of regulatory compliance, Design Control, and software and project management in the medical device industry. Her expertise includes the development of the software sections for regulatory submissions (IDE, 510(k), PMA, CE mark), software development processes, software verification and validation and software documentation for a variety of medical systems and devices, ranging from mobile medical apps, to digital radiography systems. Prior to her consulting work, she held positions at R2 Technology as Director of Engineering, at Laserscope as Director of Systems Engineering, at Diasonics as Systems Engineering Manager, in addition to positions at Acuson and other medical device companies.
Formal discussion and questions will end between 8:30 - 8:45 pm to allow time for networking after the roundtable presentation.
ONLY Check or Credit Card accepted at the door.
Moderator: George Marcel, Quality Assurance and Compliance Management Consultant
Location: Triple Ring Technologies, 39655 Eureka Dr., Newark, CA 94560 (Note: Use entrance below 39667 Suite Address - Last entrance right of main entrance at end of building)
Materials: Handouts provided. Please limit distribution to immediate personal professional use only.
Food: Snacks equivalent to a light meal and beverages are provided at each event at no additional cost.
Email: To be added to or removed from our email list, contact George Marcel, email@example.com.
Questions: For information about this session, contact George Marcel, firstname.lastname@example.org.
NEXT THREE UPCOMING ROUNDTABLES (4th Wednesday @ Triple Ring Technologies) ----
AUGUST 27th - Northern California Medical Device Industry Update & Quality Skills for Employment Readiness
SEPTEMBER 24th - TBA
OCTOBER 22nd - TBA