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ISO 14971:2019 – Quality System Impact

June 24, 2020 @ 6:00 pm - 7:30 pm

ISO 14971:2019 – Quality System Impact

June 24, 2020

6:00 pm – 7:30 pm

1.5 Hours Towards Your RAC Recertification

 

Location:  Webinar

  Click Here to Register Via Eventbrite

 

Program Manager: Kim Walker, MS, RAC (US & EU), FRAPS, Global Regulatory, Quality, & Clinical Consultant

 

 Speaker: Kim Trautman, Executive Vice President,
Medical Device International Services, NSF International

The new edition of ISO 14971:2019, Medical devices – Application of risk management to medical devices, has new definitions and updated requirements, as well as three informative annexes. Come and hear about the details of the 2019 revision and how this will impact your Quality Management System (QMS).

Topics covered include:

  • An overview of the ISO 14971:2019 changes and how these changes will affect the technical documentation throughout the medical device lifecycle
  • Why device manufacturers should pay special attention to language around benefit-risk analysis, evaluation of overall residual risk, and production and post-production activities
  • How to incorporate the ISO 14971:2019 changes into your ISO 13485:2016 QMS
  • Understand the correlation between risk management, clinical evaluation, and other post-market surveillance activities to ensure the necessary linkages and references needed in multiple QMS procedures in order to comply with new Global Regulatory expectations

 

Cost:

OCRA Members: $25

Non-Members: $100, includes 1-year OCRA membership (Purchase Membership First)

Government and Student Members: $10, with student/government ID

Speaker Bio

Kim Trautman, Executive Vice President, Medical Device International Services, NSF International.  Kim is an experienced Medical Devices and In Vitro Diagnostics Executive Vice President with 26 years of working at the U.S. FDA Center for Devices and Radiological Health (CDRH) and working with Regulatory Agencies around the globe. Industry experience as well as regulatory agency experience. Demonstrated history of working collaboratively with industry, regulators and patient groups for the betterment of public health. Executes medical device regulatory services and recently developed a formal Education/Training business, as well as an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body in Ireland for EU IVDR/MDR Designation.

  

 

 

OCRA Registration Instructions

It is important that you register with the email address where you want the webinar information sent and with the name you want to appear on the certificate of attendance.

 

Registration deadline is June 23rd

 

No same day registrations will be allowed.

 

OCRA’s non-profit Federal Tax ID# 33-0630455

 

Cancellation Deadline:

For a refund, please email your cancellation request to OCRA Program Chair (ocraprogramchair@gmail.com) by June 17, 2020.

 

If you have any questions or require additional information, email OCRA Program Chair (ocraprogramchair@gmail.com).

 

Registration Issues:
 Click Here to Register via Eventbrite:
https://www.eventbrite.com/e/iso-149712019-quality-system-impact-tickets-106835018416?aff=ebdssbonlinesearch 

 

Details

Date:
June 24, 2020
Time:
6:00 pm - 7:30 pm
Event Categories:
,

Venue

Online