Welcome to the INCOSE Heartland Chapter home page! On this site, you will find information about upcoming events, activities that we sponsor, news items of interest to the Heartland chapter community, and chapter resources.
The INCOSE Heartland Chapter serves INCOSE Members and the Systems Engineering (SE) community within the state of Iowa and some areas immediately surrounding Iowa. Although the chapter generally operates centrally out of the Cedar Rapids and Waterloo areas, the chapter does have a local presence in other cities. In addition, access to meetings and other activities is provided over the internet to the extent possible.
Contact us at heartland@incose.net to get in touch with the Chapter's leadership team and get engaged with to the INCOSE Heartland Chapter!
Heartland Chapter Officers/BoD: All Positions Open (Statewide, Iowa).Committee Positions: All Positions Open (Statewide, Iowa).
Learn more by attending the next Heartland Chapter Meetingor by registering your interests in the INCOSE Chapter and GLRC Leadership and Volunteer Registry System.
Jun 20, 2019 6:00 PM - Jun 20, 2019 8:00 PM Central Standard Time
The European Union has released a sweeping Medical Device Regulation (MDR) that goes into effect for all Medical Devices sold in Europe, next year. This presentation will discuss the unique role of systems engineering in the management of documentation required by the MDR Technical File. We will discuss how to plan a technical file transitions to the MDR, “state of the art” and some new requirements that have a large impact. The MDR expands on ISO-14971 with related requirements for benefit-risk analysis, clinical evaluation, and post market surveillance. Last and certainly not least, we will discuss the issues related to labeling requirements changes.
TOPIC: SE & EU Medical Device Regulations
SPEAKER: Jamie Roman
6:00 - 6:30 pm - Dinner & Networking 6:30 - 6:45 pm - Introductions & Announcements 6:45 - 8:00 pm - Presentation and Q&A 8:00 pm - ??? - Additional Networking
LOCATIONS: We offer multiple locations throughout the Chicagoland area and online. Visit the Chapter registration page to see which locations are available this month.
EVENT REGISTRATION: Event Registration
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