ISO 13485:2016 - What's Changing and What It Means for Medical Device Companies

Duration: 90 Minutes
This webinar focuses on what quality managers, quality system engineers, quality auditors and other personnel involved in quality system implementation will want to know about the upcoming revision and strategies of ISO 13485.
Medical Device Companies
Instructor: Mark Swanson
Product ID: 501242
In this webinar, a member of the ISO working group (Mark Swanson) will present an overview of the significant changes coming in this revision along with interpretations gleaned from the working group meetings on the reasons driving the change, the application of risk management throughout the product life-cycle and other updates in the requirements along with the likely timeline for implementation of the revision.

Objectives of the Presentation
  • Understand the general use of ISO 13485 standard
  • Understand the reasons driving the changes to ISO 13485 for this third revision
  • Understand what is changing in ISO 13485
  • Understand how these changes affect an organization involved in the medical device industry
  • Be able to use the content to implement the required changes in an organization to obtain or maintain a quality certification
  • Determine other considerations for obtaining or maintaining a certification for an ISO 13485 quality system
Why Should you Attend
This webinar focuses on the updates related to the general use of the standard and the high level overview of those coming changes. This training is important for Medical Device companies to prepare for those changes and the potential impact they may have on their business.

Areas Covered
  • A brief overview of the ISO 13485 standard, and why it is changing
  • Key changes coming with ISO 13485:2016
  • The rationale behind these changes
  • When you can expect the changes to take effect
  • Next steps for organizations looking to implement or transition to ISO 13485:2016
  • Other considerations for medical device organizations
Who can Benefit
  • Medical Device Industry
  • Suppliers to medical device manufacturers
Topic Background
The ISO 13485 standard is the sector quality management standard for medical device organizations. It takes general quality system requirements for all organizations intending to provide products or services to customers and modifies it for application within the highly regulated medical device industry. In addition, it is recognized by several countries and regions as the internationally agreed way to implement common regulatory concepts that will support maximizing the potential benefits of making the strategic decision to implement a quality management system.
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Mark Swanson (ASQ CMQ/OE, CQE, CBA) is the President and lead consultant of H&M Consulting Group, a group focussing on helping small to mid-sized companies having the same regulatory and quality systems knowledge as the large medical device companies. In addition to this, Mark is also the Director of the Medical Technology Quality Graduate program at St. Cloud State University.

Mark has spent the last three years as an active member of ISO Technical Committee 210 (TC210), Working Group 1 (WG1) working on the revision of ISO 13485:2003 and has also participated with ISO TC176, WG24 on the next version of ISO 9001. This work includes discussions regarding the impact of changes in the ISO quality management system standards, the integration of various standards and how to effectively integrate the different management system standards and other regulations into a single quality management system.
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