Twin Cities Chapter: Scaling a Human Factors Program According to a Medical Device’s Risk Profile and User Expectations

RAC Credits
Wednesday, 21 February 2018 (5:30 PM) - Wednesday, 21 February 2018 (8:30 PM) (Central Time (US & Canada))
12201 Ridgedale Dr
Minnetonka, Minnesota, USA, 55305-1903

Wednesday, 21 February 2018
5:30-8:30 pm CST
Sheraton Minneapolis West Hotel
12201 Ridgedale Drive
Minnetonka, MN 55305
+1 952-593-0000

Today, most medical device manufacturers have embraced human factors as both a regulatory and commercial imperative. There’s an understanding that human factors must be applied in the course of developing a Class II or Class III product, principally to (1) help ensure safe and effective use, and (2) meet FDA’s expectations and/or comply with IEC 62366-1. Manufacturers recognize that these consumer and software products have raised expectations among users that medical devices will be user-friendly.

Join professionals from your region to learn how manufacturers can scale their human factors work relative to a device’s class (I, II or II), the nature of the users (e.g., clinicians, laypersons) and the market (competitive, non-competitive.) Session attendees will come away with a firm idea of the scope of human factors work that is required to satisfy regulator’s expectations, as well as how much is optional and worthwhile to boost a device’s marketability.

This event is brought to you by the RAPS Twin Cities chapter and is intended to facilitate networking among regulatory personnel. A meal will be available for all attendees. RAC holders may claim two RAC recertification credits.

Featured speaker:
Michael Wiklund, general manager, human factors engineering, Underwriters Laboratories

Registration Information:
RAPS Members: $50
List: $65

*Call RAPS Customer Service at +1 301 770 2920 ext. 200 to learn about the special student registration rate.