ISO 13485:2016 Foundations Training

Establish a working knowledge of regulatory requirements needed to develop and produce medical devices

Gain an in-depth understanding of the ISO 13485:2016 Medical Device Quality Management System standard when you enroll in this instructor-led course. Designed for anyone seeking to learn about quality management requirements for designing, developing, and producing medical devices, this ISO 13485 course distills essential information about the medical device quality management system.
We offer both in-person and virtual learning options, and the two-day ISO 13485 training class concludes with a written competency exam.

Course Details

  • Length: 2 days
  • CTUs: 1.6
  • Competency Unit: MD
  • Audience: Anyone seeking to understand the requirements of an ISO 13485 Medical Device QMS, including quality assurance professionals, ISO project managers, compliance managers, and regulatory personnel
In-Person Sessions 👨‍🏫 - $1195
    • Describe the ISO 13485:2016 QMS standard and its development
    • Identify medical device QMS terms
    • Describe the intent and requirements of ISO 13485
    • Determine the evidence needed to demonstrate conformity to ISO 13485
    • Apply the process approach and Plan-Do-Check-Act (PDCA) methodology
    • Describe the relationship between ISO 13485:2016 and applicable regulatory requirements

    The instructor went through the material clearly and methodically and provided many examples from experience to illustrate different clauses of the standard. She helped to make the material more engaging and interesting.

    Course feedback from a student, 2021

    Why DEKRA?

    Industry-leading accreditation and unparalleled experience

    DEKRA Training (formerly AQS) offers a full range of training in support of organizational improvement and implementation of international management system standards.
    This Exemplar Global-certified course for ISO 13485:2016 meets the training requirements for Exemplar Global Quality Management Systems Auditors and Provisional Auditors.
    Have questions? Contact us
    DEKRA Training

    8990 Springbrook Dr. NW

    Suite 210

    Minneapolis MN 55443