The New EU Medical Device Regulation – Overview for Engineers

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Will discuss on following topics:

-        Overview of the new rules (40,000’ view)

-        Focus on sections most likely to affect engineers

         o   Revised essential requirements including suggestions for selecting standards

         o   State of play of the harmonized standards

         o   Expectations for field follow-up

-        Transition information (when will compliance be required)



  Date and Time

  Location

  Hosts

  Registration



  • Evonexus
  • 5151 California Ave, Suite 150
  • Irvine, California
  • United States 92617

Staticmap?size=250x200&sensor=false&zoom=14&markers=33.6405168%2c 117
  • Harshad Parmar 

    949-973-1049

     

     

  • Co-sponsored by EMBS OC
  • Starts 04 December 2016 12:00 PM
  • Ends 18 January 2017 03:00 PM
  • All times are US/Pacific
  • No Admission Charge
  • Register


  Speakers

Christine Ruther of IEEE Orange County EMBS Chapter

Topic:

The New EU Medical Device Regulation – Overview for Engineers

Will discuss on following topics;


-        Overview of the new rules (40,000’ view)


-        Focus on sections most likely to affect engineers


         o   Revised essential requirements including suggestions for selecting standards


         o   State of play of the harmonized standards


         o   Expectations for field follow-up


-        Transition information (when will compliance be required)

Biography:

Christine Ruther received her undergraduate and graduate education in Ohio.  After completing a BS in Physics at Xavier University, she went on to earn a MS in Biomedical Engineering at The Ohio State University.  She is a licensed professional electrical engineer in California.

 Ms. Ruther has extensive experience in the medical device industry including experience with wireless devices.  She has significant strengths in compliance and regulatory engineering.  Ms. Ruther held the post of Director of Product Development and Regulatory Affairs for AirBed Corporation in Anaheim, California.  There she assisted in design of the company’s products, coordinated regulatory compliance and performed product failure analysis.  After working at AirBed, she joined TUV Product Service working from their San Diego, California, office.  At TUV, Christine was the technical manager for the Medical Device Testing group in the US and directly managed the Medical testing and ISO/CE auditing activities for the southwestern region.  As well as managing, Ms. Ruther specified and conducted compliance testing for medical devices and performed audits of medical device manufacturers.  After four years at TUV, Christine became the Compliance Manager for Cardiac Science in Irvine, California.  Her career advanced further when she joined the medical telemetry division of GE Medical Systems as a Lead Professional Systems Engineer.

 Ms. Ruther now works directly with a wide range of clients in compliance & safety engineering, and in quality & regulatory affairs.  She works mainly with manufacturers, from start-ups through Fortune 500 companies.  But, she has also worked for government agencies such as the National Institute of Standards and Technology (NIST) and the National Standards Authority of Ireland (NSAI), as well as standards and laboratory oversight agencies such as the American National Standards Institute (ANSI).  Her knowledge of global regulations from MDD/AIMDD and RED through FDA and FCC coupled with her engineering abilities in risk analysis and design controls makes her a valuable asset to device teams.

 Christine lives with her husband, Greg Adams, in Mission Viejo, California.  She has an active interest in professional organizations.  She volunteers with the local Institute of Electrical and Electronics Engineers (IEEE) chapter and other local groups.





Agenda

6:00PM - 6:30PM Networking and Dinner

6:30PM - 7:30PM Presentation

7:30PM - 8.00PM Wrap Up

Dinner will be provided at No cost