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Course Details

Introduction to ISO 13485:2016

Course Area

Medical Devices

Course Duration

1 Day

Continuing Education Units

0.8

Course Fee

USD $795.00

Early Bird Price*

USD $695.00

Upcoming Sessions
Oct 28, 2022 - Live Online - Full DayEnroll

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* Subject to availability

Course Details

This course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with ISO 9001:2015, the European Medical Device Regulations and US FDA's Quality System Regulation. The relationship with ISO 14971 “Application of Risk Management to Medical Devices” is also explored during the course.

How will I benefit?

This course will help you:

  • Take the first steps towards ISO 13485:2016 certification
  • Understand how you can better meet regulatory requirements leading to increased patient safety
  • Find ways to increase efficiency and cost savings through quality management
  • Monitor supply chains to achieve continuous improvement
  • Develop safe and effective medical devices
  • Motivate employees through Continuous Education

What will I learn?

On completion, you should gain the knowledge and skills to:

  • Explain the use of ISO 13485:2016 as the basis for a QMS for medical device manufacturers
  • Identify the relationship between ISO 13485:2016 and European Medical Device Regulations
  • Recognize the use of ISO 13485:2016 as the basis of regulatory requirements worldwide

Who should attend?

Senior management, quality managers, regulatory affairs managers, internal and external auditors, consultants and anyone involved with the implementation of the standard.

All Upcoming Course Dates

Date and Time Location Fees Enroll
Oct 28, 2022 11:00 AM - 7:30 PM ET
Live Online - Full DayUSD $795.00Enroll

The venues for scheduled courses are tentative until receipt of a course confirmation from BSI.

Live Online Classes

Certified, convenient, and interactive, with no travel costs.

Private Class

Interested in a private or customized version of this course? Request a quote.

Questions?

For questions regarding any of our courses, contact us or call 1.800.217.1390.

Questions?

For questions regarding any of our courses, contact us or call 800.217.1390 (USA) 800.862.6752 (Canada)

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