Date: Tuesday, January 23, 2017
Registration and continental breakfast: 7:30-8AM
Presentation: 8AM to 4PM, Lunch at Noon
Post Event Networking: 4PM at Surly Brewing
$149/per person: REGISTER HERE TODAY
Developing software in compliance with the FDA Design Control regulations and international standards is challenging.
This one-day course provides background and suggestions for developing software in a manner that meets applicable FDA guidance documents and international standards, such as IEC 62304.
Discussions will center on key topics such as:
a. Software Planning / Classification
b. Software Requirements / Traceability
c. Risk Management
d. Design Reviews
e. Software Testing (unit level, integration, design verification)
In addition, there will discussion and insight on the recently issued FDA Guidance Documents on Cybersecurity, Mobile Apps, and Usability that are impacting software development.
There will also be time dedicated to discussing options for bringing legacy software device and systems into compliance with new regulations.
Interactive group discussion will be encouraged to facilitate learning.
This one-day course will cover aspects of a broad range of subjects in the area of medical software development. Depth of discussion will be driven by time and attendee interest. Follow on programs with more detail may be offered if interest is shown by attendees.
Software engineers, project managers, quality managers, software quality professionals, RA/QA staff, and anyone who needs to develop cost-effective processes and procedures that will enable their organizations to deliver high quality software-based medical devices that comply with FDA regulations and international standards.
This course is appropriate for people who are new to the medical device industry.
$149 per person -- REGISTER HERE TODAY!