ISO 13485:2016 & Medical Device 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!
Exemplar Global Certified Courses

    ISO 13485:2016 Certified Lead Auditor Training

    Exemplar Global Competency Units MD, AU, TL
    • Fully understand and interpret the requirements of ISO 13485:2016
    • Understand how to apply the requirements of the ISO 13485:2016 standard
    • Plan, manage, and schedule an audit program
    More Medical Device Courses
    EU 2017/745 Medical Device Regulations

    EU 2017/745 Medical Device Regulations

    3 Days - 2.4 CTUs

    • Understand the structure of the new MDR
    • Recognize the significant changes compared to MDD
    • Know the key aspects of requirements for CE Marking
    • Examine the changes in device definitions and MDR terminology
    • Analyze the significant aspects affecting the device manufacturer
    • Interpret the range of technical documentation required
    • Discuss the key changes impacting conformity assessment
    • Describe the transition timeframes, current position
    MDD to MDR Transition
    Process Validation
    Understanding and Implementing
    Have questions? Contact us
    DEKRA Training

    8990 Springbrook Dr. NW

    Suite 210

    Minneapolis MN 55443

    Please note that participating in this or any DEKRA trainings should not in any way be linked to (the outcome of) any certification activities carried out by other DEKRA entities.