ISO 13485:2016 Training

The medical device industry is extremely complicated and competitive. We offer a number of courses to train auditors and staff on the standards of ISO 9001, ISO 13485, and more!

ISO 9001:2008 36-Hour Certified Lead Auditor with Medical Device Focus (ISO 13485)

Certified by Exemplar Global

  • Fully understand and interpret the requirements of ISO 13485
  • Understand the differences between ISO 9001 and ISO 13485, including the critical differences in requirements for continual improvement and customer satisfaction
  • Understand how to apply the requirements of ISO 9001 and the ISO 13485 Standards during 5 practical audit exercises conducted during the class

Note: This course covers the ISO 13485:2016 revision as well as ISO 9001:2008. ISO 13485:2016 is not aligned with ISO 9001:2015; therefore, ISO 9001:2015 is not covered as part of this course.

Register for a Public Class

Process Validation for Medical Device, Pharmaceutical, and Combination Product Manufacturing

  • Fully understand the regulatory requirements for process validation and their relationship to the Medical Device QSR and the Pharmaceutical cGMPs
  • Gain knowledge to help manage a successful validation project
  • Fully understand and successfully interpret the GHTF/SG3/N99-10:2004 Guidance on Process Validation

Register for a Public Class

ISO 9001 Internal Auditor With Medical Device Focus (ISO 13485)

Certified by Exemplar Global

  • Fully understand and successfully interpret the ISO 13485 requirements
  • Understand how to audit using the process approach
  • Ask audit questions that get results

ISO 13485 2-Day Internal Auditor

  • Fully understand and successfully interpret the ISO 13485 requirements
  • Understand how to audit using the process approach
  • Ask audit questions that get results

Note: Unlike the 3-day version, this course is not Exemplar Global-certified.

Understanding and Implementing ISO 13485

Use this training to jumpstart (or re-start) your ISO 13485 Implementation Project

This course is designed for participants who need to implement ISO 13485 within their organization. Participants will understand the requirements and the implications for their organization and will acquire tools that will help them:

  • Fully understand and successfully interpret the ISO 13485 requirements
  • Achieve the benefits that are inherent within the ISO 13485 requirements
  • Proceed with their project in a timely, cost effective manner

2-Day Documentation for Medical Device

This course places documentation in its proper place as one of many tools used by organizations to assure results. People attending this course will understand and apply their newly acquired skills to determine: when a document is needed, alternatives to documentation that may achieve better results, and how to configure documentation to meet the unique needs of the situation to be managed and the people performing the task.

ISO 13485 (ISO 9001) Requirements from A to Z

Online Course - $379

The class is based on a portion of an Exemplar Global approved ISO 13485 Certified Lead Auditor class. This class provides on-line access to ISO 9000 (vocabulary standard) and over 20 downloadable handouts such as: an ISO 13485 checklist, a Student Textbook, Study Tips, a before-class assessment and after-class objectives, and so on. Students must apply what they learned by completion of an assignment for marking by an instructor. If students want a copy of the ISO 13485 standard, they must provide their own, however, the standard is not a material requirement for the class. The class consists of a series of lessons, illustrations, diagrams, interactive exercises and quizzes. Successful completion of the class will result in a certificate for 20 contact hours (2.0 CEU's).

Enroll in the Online Course

Have questions? Contact us

DEKRA Audits

8990 Springbrook Dr. NW

Suite 210

Minneapolis , MN 55443

+1 800.633.2588
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