Equip Your Medical Device Quality Management Team

ISO 13485 Courses & More

Your industry is growing – and fast. Innovative therapies and cutting-edge tools require detailed compliance teams. Keep your customer pipeline healthy and minimize defects. Learn best practices to ensure that your products meet the latest standards for safety and quality.

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SAE is the Leader in Quality Management Standards Training

  • Lower cost than many other providers.
  • Convenient online courses.
  • One year of course access.
  • Precise standards knowledge.

Trusted by Phillips Medical, Bayer, Baxter International, and other OEMs and suppliers large and small.

ISO 13485:2016 Courses

ISO 13485 provides requirements for quality management practitioners involved in the design, production, installation and servicing of medical devices and related services.

ISO 13485:2016 Lead Auditor Training

On-Demand / Duration: 24 Hours

Upgrade your expertise with a deep understanding of ISO 13485, how to interpret it, and implement your organization. Take on a productive role in your organization’s auditing process. This comprehensive training will help you identify non-conformance to the standard, and lead audits for your organization or beyond.

ISO 13485:2016 Auditor Training

On-Demand / Duration: 15 Hours

Quickly and efficiently learn the requirements of ISO 13485 and take a greater role in your organization’s quality management system. Designed for individuals who are involved with quality management systems, implementation, and auditing to the ISO 13485 series of standards for medical devices and related services.

ISO 13485:2016 Standard Training

On-Demand / Duration: 10 Hours
Learn to interpret the clauses within ISO 13485 and help your organization meet regulatory requirements.
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ISO 13485:2016 Overview Training

On-Demand / Duration: 4 Hours
Get a high-level overview of the requirements of this standard and its requirements for the audit process.
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Quality Management Courses
from SAE

ISO 13485 not for you? Explore our range of QMS courses.

In a highly competitive industry, quality is everything. SAE powers your growth and helps you stand out and build customer trust.

SHOW COURSES

Quality Management Courses
from SAE

ISO 13485 not for you? Explore our range of QMS courses.

In a highly competitive industry, quality is everything. SAE powers your growth and helps you stand out and build customer trust.

HIDE COURSES

ISO 9001:2015 Auditor Training

On-Demand / Duration: 15 Hours
Quickly and efficiently learn how to conduct an ISO 9001:2015 audit. At the completion of this course, you will be able to assume a productive role in an audit of your organization’s Quality Management System as outlined in ISO 9001 and ISO 19011 and interpret how the requirements should be implemented within your organization.

Design and Process Failure Modes and Effects Analysis (FMEA)

Virtual Live Seminar / Classroom / Duration: 2 Days
This step-by-step process helps designers and manufacturers anticipate and solve potential problems early, saving time and reducing defects. Learn the five types of FMEAs and get practical instruction on how to build design and process FMEAs. Then, apply these principles through practical exercises.

Introduction to Additive Manufacturing

Corporate Learning Engagements only / Duration: 2 Days
Additive manufacturing (AM) shows enormous promise beyond just prototyping. Learn key benefits and considerations for using AM, and engage in practical exercises using CAD tools. Participants gain a better understanding of design approaches, QA concerns, and evolving technologies.

SAE ISO Training Drives Value

TRUSTED

SAE has trained over 30,000 employees and individuals in ISO 9001, ISO 13485, ISO 14001, GLP, GMP, ISO 16949 and other standards. Satisfaction guaranteed. 

EXACT

Developed by experts, our courses use the exact excerpts of the standards or regulations with no distortions and inaccuracies resulting from paraphrasing or a trainer's "own" interpretation. 

CONVENIENT

SAE offers on-demand and virtual training options, so you can choose the ISO option that fits your current work model. Complete the courses from anywhere, with no time limits constraining your learning pace.

What participants are saying...

“The amount of information and understanding I gained from taking the course was invaluable.”

—Quality Staff from TTM Technologies

“The amount of information and understanding I gained from taking the course was invaluable.”

—Quality Staff from TTM Technologies

“The amount of information and understanding I gained from taking the course was invaluable.”

—Quality Staff from TTM Technologies

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