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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

More ISO 13485 Training Options

Highlighted Topics

  • Major requirements of the ISO 13485:2016 standard

  • Types of evidence needed to demonstrate conformity to ISO 13485:2016

  • Relevant terminolgy for medical device quality management systems

  • The relationship between ISO 13485 and applicable regulatory requirements

  • 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

All attendees are required to bring their own copy of the standard ISO 13485:2016 Quality Management – Requirements For Regulatory Purposes. Copies will not be provided for you.

This is a two-day, instructor-led course available online or in-person. The course will cover ISO 13485:2016 as a standard, with with a corresponding competency exam (MD).

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


Industry-leading accreditation and unparalleled experience

Exemplar Global-certified course

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

+1 800-633-2588