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A better world through a systems approach

C-NO Chapter Meeting - December 2019

Topic:  Medical Device Risk Management

Speaker:  Jim Richards


Medical devices are globally regulated and safety and effectiveness are mandated to have controlled design processes that consider safety risks throughout the product lifecycle. The talk will present an overview of applicable standards and how product risk management interacts with the design process. Some detailed examples of design guidance from the standards will be presented.


Senior Systems Engineer at Philips Healthcare since 2005 with experience as lead for teams of system engineers, physicists, and system designers to deliver top tier CT products with a focus on problem solving and integration of new technologies. Extensive experience in design controls and quality systems and as a risk management process owner. Support for the business as a lead for compliance audits with TUV, FDA and other international and independent auditors. Experience with product and process CAPA’s and development of training for post market risk management and complaints handling. Past experience includes systems design, physics and electrical engineering in the development of advanced technologies and feasibility studies for product development of multiple CT scanner family platforms and imaging systems development for invasive cardiac, cardiovascular and x-ray products. Working in the Medical device industry since 1979.

Member of IEEE and the following societies:

  • IEEE Electromagnetic Compatibility Society Membership
  • IEEE Product Safety Engineering Society Membership
  • IEEE Reliability Society Membership
  • IEEE Systems Council

Outside Interests include:

  • Father of 2 teen boys
  • Outdoor sports - hiking, canoeing and kayaking
  • Nature Photography
  • Music – Guitar, Fiddle and Mandolin.

Venue: Webinar (your computer) or two locations:

  • NASA Glenn, Building 162, room 209 (NASA-badged members/guests)
  • Philips Healthcare/Orange Village (Philips Healthcare-badged members/guests)

Registration Requested:  Register Here ( via EventBrite


NASA Glenn location:
Building 162, room 209.

Philips Healthcare/ location
Philips Healthcare,
100 Park Avenue, Suite 300
Orange Village, OH, 44122

Philips Healthcare Map
Note: This is in the Pinecrest development in Beachwood/Orange Village and is located East of I-271 in between Harvard Road and Chagrin Blvd exits.

  • From Parking Deck, one can walk out onto Park Avenue to the front entrance on street level (100 Park Avenue).
  • Please assemble in the lobby (first floor) and Sastry Kasibhatla [(440)-241-3731] will escort you to the 3rd Floor.
  • Visitors will then be able to sign in visitors log on 3rd Floor.