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
An experienced DEKRA instructor comes to you. We can even customize training to your needs.
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Our three-day Certified Internal Auditor class covers the basics of the standard and how to conduct an audit. This does not include Lead Auditor competency unit
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Our four-day Lead Auditor option adds certified competency units on conducting audits, as well as leading a team of auditors
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- 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.