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ISO 13485:2016 Medical Device QMS Transition Training

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

Now includes more workshops, tips, and best practices focused on auditing to the revised standard, so that you’ll be ready for your ISO 13485:2016 upgrade audit. The updated course also features discussions on ISO 13485:2016’s relationship with MDSAP and the EU’s new Medical Device Regulation (MDR) – a strong understanding of ISO 13485:2016 is a key preparatory step for MDSAP and EU MDR transitions.

ISO 13485:2016 provides clarifications and new requirements to improve medical device safety and performance. Major changes in the standard 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, you will thoroughly review the revised standard, assess its impact on your quality management system, and gain actionable knowledge to make your ISO 13485:2016 transition easier and more successful.

Highlighted Handouts and Reference Documents  

  • ISO 13485:2016 Gap Analysis Checklist
  • Correlation Matrix Between ISO 13485:2016 and QSR, and QSR Compared to ISO 13485:2016
  • Sample Software (SW) Validation Plan and Report
  • Sample Audit Evidence for All Clauses in 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 1.800.472.6477  |  On-Site training available, learn more »

There are currently no public dates scheduled. All our courses are available to be held at a location of your choice. Please contact us for more information.

Course Objectives

  • Describe the background, drivers, and transition period for the ISO 13485:2016 standard.
  • Describe the relationship of ISO 13485 to the European Union (EU) directives/regulations, US 21 CFR 820, and MDSAP.
  • Explain the changes, intent, and guidance for ISO 13485:2016 (Introduction, Scope, Definitions, Clauses 4-8) and practice assessing gaps and audit readiness
  • Identify best practices in process management, risk management, risk-based approaches, and usability.
  • Describe how to integrate risk-based thinking and use a risk-based approach for QMS processes and auditing.
  • Describe the purpose, entities, benefits, and challenges associated with the MDSAP.
  • Describe MDSAP processes, audit tasks, and the nonconformity grading scale.
  • Recognize the challenges associated with medical device transitions and the available resources.

Course Topics

  • Relationship between ISO 13485:2016 and EU device directives/regulations, FDA’s QSR, and MDSAP
  • Difference between risk-based control of processes and risk management for product safety
  • Change and intent in the new standard, with opportunities for gap assessment and audit practice

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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Bring any of our classes to your location - Oriel STAT A MATRIX on-site training is the perfect solution for training groups of five or more employees or launching a companywide training effort. It's cost-effective, completely customizable, and absolutely hassle-free. For more information, call 1.800.472.6477 or Contact Us.

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