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Transition to ISO 13485:2016

You have until March 2019 to update your current ISO 13485 certification. Make sure you’re prepared!

ISO 13485:2016 provides clarifications and new requirements to improve medical device safety and performance. Major changes include an increased focus on risk management throughout the product life cycle, the supply chain, as well as device usability and postmarket surveillance requirements.

In this course – which was developed by a leading member of the ISO/TC 210 Working Group responsible for creating ISO 13485:2016 – you will review the revised standard, assess its impact on your quality management system, and work on a plan to update your quality system to meet the new requirements.

Highlighted Handouts: 

  • Gap Analysis Checklist
  • Correspondence Between ISO 13485:2016 and the US Quality System Regulation (QSR) and QSR to ISO 13485:2016
  • QMS Transition Project Plan Template

Upcoming Dates and Locations

Please Contact Us if you need additional information or if you don't see a date that works for you. To register by phone, call 1.888.532.6360  |  On-Site training available, learn more »

Location Start Date Days Cost Public Course On-Site
San Francisco Area, CA 08/21/2017 2 $1595.00 Add to Cart CONTACT US
Boston, MA 08/28/2017 2 $1595.00 Add to Cart CONTACT US
Orlando, FL 09/18/2017 2 $1595.00 Add to Cart CONTACT US
Minneapolis, MN 09/25/2017 2 $1595.00 Add to Cart CONTACT US
San Diego, CA 10/02/2017 2 $1595.00 Add to Cart CONTACT US
Chicago, IL 10/09/2017 2 $1595.00 Add to Cart CONTACT US
Austin, TX 10/16/2017 2 $1595.00 Add to Cart CONTACT US
Irvine, CA 10/23/2017 2 $1595.00 Add to Cart CONTACT US
San Jose, Costa Rica 10/23/2017 2 $1595.00 Add to Cart CONTACT US
Edison, NJ 10/30/2017 2 $1595.00 Add to Cart CONTACT US
Indianapolis, IN 11/06/2017 2 $1595.00 Add to Cart CONTACT US
San Francisco Area, CA 11/13/2017 2 $1595.00 Add to Cart CONTACT US
Orlando, FL 11/29/2017 2 $1595.00 Add to Cart CONTACT US
Boston, MA 12/04/2017 2 $1595.00 Add to Cart CONTACT US
Minneapolis, MN 12/11/2017 2 $1595.00 Add to Cart CONTACT US

Course Objectives

  • Describe the influencers and change drivers in the new ISO 13485 standard.
  • Understand and interpret the changes introduced in ISO 13485:2016.
  • Discuss the emphasis on risk management, software validation, and the role of MDSAP.
  • Begin a gap assessment of the QMS and associated documentation.
  • Understand the transition period and frequently asked questions.
  • Establish an action plan to achieve and maintain certification to ISO 13485:2016.

Course Topics

  • The major change drivers influencing the revised ISO 13485 standard
  • Review and interpret the changes in the new standard, and learn how these changes will impact organizations
  • The process approach, risk management, software validation, and the impact on auditing
  • The transition period and frequently asked questions

Who Should Attend

Organizational top management, other senior managers, operational managers, management representatives, quality managers, compliance managers, auditors, and other professionals engaged in the implementation or auditing of their organization’s quality management system. 

Number of Days: 2
CEUs: 1.5
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