Medical Device Compliance Training
Innovate Safely, Comply Confidently
Get certified in FDA and ISO standards with training that keeps you compliant at every stage of the device lifecycle. From QSR to 510(k) submissions, ensure safety and market readiness.
Introduction to 21 CFR 11
Learn about Part 11 of Title 21 of the Code of Federal Regulations, which establishes the United States Food and Drug Administration (FDA) regulations for electronic records and electronic signatures.
Introduction to ISO 13485 & FDA QSR
This course is for professionals in the medical device industry who want to learn about ISO 13485. Gain experience and a deeper understanding of the ISO 13485 Standard and requirements.
Implementing ISO 13485:2016
This course will introduce the requirements of ISO 13485 and outline the steps for building an ISO 13485 compliant quality management system.
European Medical Devices Regulation (EU MDR) Training
The European Medical Devices Regulation (EU MDR) applies to all manufacturers of medical devices sold in Europe. Gain an understanding of the EU MDR and how the new requirements will affect your organization.
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