Call Us: 855.476.2701
Follow Us:

ISO 13485 Training

Foundation

ISO 13485 Medical Devices Quality Management System Foundation

ISO 13485 Foundation

Become acquainted with the best practices of Medical Devices Quality Management Systems (MDQMS) based on ISO 13485.

2 Days

LENGTH

$1,350

COST

14
CE/PDU
CREDITS

REGISTER

Become acquainted with the best practices of Medical Devices Quality Management Systems (MDQMS) based on ISO 13485.

View Next Training Date

SUMMARY
ISO 13485 Foundation training enables you to learn the basic elements to implement and manage a Medical Devices Quality Management System (MDQMS) as specified in ISO 13485. During this training course, you will be able to understand the different modules of a MDQMS, including MDQMS policy, procedures, performance measurements, management commitment, internal audit, management review and continual improvement.

After completing this course, you can sit for the exam and apply for the "PECB Certified ISO 13485 Foundation" credential. A PECB Foundation Certificate shows that you have understood the fundamental methodologies, requirements, framework and management approach.

Who Should Attend?

  • Individuals involved in Medical Devices Quality Management
  • Individuals seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS)
  • Individuals interested to pursue a career in Medical Devices Quality Management

COURSE AGENDA

DURATION: 2 DAYS

DAY 1

Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485

DAY 2

Medical Devices Quality Management System requirements and Certification Exam

Learning Objectives

  • Understand the elements and operations of a Medical Devices Quality Management System (MDQMS)
  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
  • Understand the approaches, methods and techniques used for the implementation and management of a MDQMS

EXAMINATION & CERTIFICATION

The "PECB Certified ISO 13485 Foundation" exam fully meets the requirements of the PECB Examination and Certification Program (ECP). The exam covers the following competency domains:

1

Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

2

Domain 2: Medical Devices Quality Management System (MDQMS)

CERTIFICATION

After successfully passing the exam, you can apply for the credential shown on the table below. You will receive the certificate once you comply with all the requirements related to the selected credential. Certification fees are included in the exam price.


Credential

PECB Certified ISO 13485 Foundation


Exam

PECB Certified ISO 13485 Foundation exam or equivalent

Professional Experience

None

MS Audit / Assessment Experience

None

MDQMS Project Experience

None

Other Requirements

Signing the PECB Code of Ethics

GENERAL INFORMATION

  • Certification fees are included on the exam price.
  • Training material containing over 200 pages of information and practical examples will be distributed.
  • A participation certificate of 14 CPD (Continuing Professional Development) credits will be issued.
  • In case of exam failure, you can retake the exam within 12 months free of charge.

Training Calendar

Please rotate your phone to see the training calendar

Enter Your Coupon Code:

Updated Price for Training:

Course
(Instructor Led)

Dates

Location

Cost

Pay Now

Request Seat

PECB Certified
ISO 13485 Foundation

(download)

Self Study Course

Online

$750

REQUEST INFO

Would you like a Foundation Training in your area?   

Contact us about ISO 13485 Foundation Training!

* = Required

Services You Are Interested In:
Training
Gap Assessment
Consulting
Internal Audit
Certification Audit
Sofware
What is plus ?

NOTE: iCertWorks will not provide requested information to personal email addresses (examples: gmail.com, yahoo.com, msn.com, etc.).

ISO 13485 Foundation Training Brochure
Click to Download Brochure (.pdf)

Looking for ISO 27001 Training?   

Contact Us
  • Address: 6991 E. Camelback Rd., D-300
    Scottsdale, AZ 85251
  • Phone: (855) 476-2701
  • Email: info@icertworks.com
  • Monday - Friday: 8:00 am - 5:00 pm
    Saturday - Sunday: Closed
  • PECB Training Platinum Partner
© 2019 iCertWorks LLC. All right reserved.