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ISO 13485:2016 Medical Device QMS Foundation

Medical devices

A must for those who will be auditing their own organization’s ISO 13485:2016 quality management system

To meet high demand, constrained budgets and travel restrictions, DNV now offers ISO 13485:2016 Medical Device QMS Foundation training in a live online environments. Take the course while at work or in your home office!

This 1-day course clarifies ISO 13485:2016 requirements and interpretations. Organizations that need to show evidence that they can provide medical devices which consistently meet customer and regulatory requirements will benefit from understanding ISO 13485.

Whether you are an ISO 13485 novice or an old pro looking to refresh your skills, this course is a must.

Who Should Attend:
This course is highly recommended for anyone involved in auditing, designing, implementing, maintaining and/or improving a medical device quality management system, or who simply want to further their knowledge of the ISO 13485 standard. 

Recommended follow-up courses:
ISO 14971 Medical Devices Risk Management,  ISO 9001:2015 QMS Foundation and Internal Auditor, Root Cause Analysis and Problem Solving

Course Highlights:

  • An in-depth look at the ISO 13485 requirements
  • Concepts, terms and definitions used by Medical Device auditors worldwide
  • Using a risk-based approach to achieve quality objectives

Class Hours: 

In Class: 8:30 a.m. - 5:00 p.m.

LiveOnline: 9:00 a.m.- 4:30 p.m. CST. 

  • LiveOnline classes are delivered in 90 minute segments followed by 30 minute breaks
  • Up to four (4) sessions per day

Cancellation, Transfer, Substitution, and "No-Show" Policy:

In-class

More than 30 days to the start date of the course, a registrant may: 
  • Request to cancel a registration and receive a full refund, or
  • Request to transfer to a different class at no charge. 
15-29 days prior to the start date of the course: 
  • Request to cancel a registration and receive a 50% refund, or
  • Request a transfer to a different class and remit a $100 fee to process a transfer.

Less than 15 days prior to the start date of the course (including no-shows on the day of the course), no refunds or transfers are provided.

LiveOnline

10 days or more prior to the start date of the course, a registrant may:

  • Request to cancel a registration and receive a full refund, or
  • Request to transfer to a different class at no charge.
9 days-24 hours prior to the start date of the course:
  • Request to cancel a registration and receive 50% refund, or
  • Request to transfer to a different class and remit a $100 fee to process a transfer.
Less than 24 hours prior to the start of the course:
  • No withdrawals or transfers
  • Fee is non-refundable.

Substitutions (another person replacing a particular registrant in a course) are permitted at any time without additional charge.

Should DNV cancel a schedule course, our liability to course registrants is limited to the amount of the course fee. The registrant would then have the option of a full refund or transfer to an alternative available course (transfer fee is waived in this situation). We recommend that registrants wait until the course date is less than 30 days out before making travel arrangements.

**To register for a course, you may click the "location" link below to pay by credit card or you can contact us to pay by invoice. 

PLEASE NOTE: 

  • There will be a 10% administration processing fee for generating invoices. 
  • Discount codes are not applicable on invoiced orders.

To meet high demand, constrained budgets and travel restrictions, DNV now offers ISO 13485:2016 Medical Device QMS Foundation training in a live online environments. Take the course while at work or in your home office!

This 1-day course clarifies ISO 13485:2016 requirements and interpretations. Organizations that need to show evidence that they can provide medical devices which consistently meet customer and regulatory requirements will benefit from understanding ISO 13485.

Whether you are an ISO 13485 novice or an old pro looking to refresh your skills, this course is a must.

Who Should Attend:
This course is highly recommended for anyone involved in auditing, designing, implementing, maintaining and/or improving a medical device quality management system, or who simply want to further their knowledge of the ISO 13485 standard. 

Recommended follow-up courses:
ISO 14971 Medical Devices Risk Management,  ISO 9001:2015 QMS Foundation and Internal Auditor, Root Cause Analysis and Problem Solving

Course Highlights:

  • An in-depth look at the ISO 13485 requirements
  • Concepts, terms and definitions used by Medical Device auditors worldwide
  • Using a risk-based approach to achieve quality objectives

Class Hours: 

In Class: 8:30 a.m. - 5:00 p.m.

LiveOnline: 9:00 a.m.- 4:30 p.m. CST. 

  • LiveOnline classes are delivered in 90 minute segments followed by 30 minute breaks
  • Up to four (4) sessions per day

Cancellation, Transfer, Substitution, and "No-Show" Policy:

In-class

More than 30 days to the start date of the course, a registrant may: 
  • Request to cancel a registration and receive a full refund, or
  • Request to transfer to a different class at no charge. 
15-29 days prior to the start date of the course: 
  • Request to cancel a registration and receive a 50% refund, or
  • Request a transfer to a different class and remit a $100 fee to process a transfer.

Less than 15 days prior to the start date of the course (including no-shows on the day of the course), no refunds or transfers are provided.

LiveOnline

10 days or more prior to the start date of the course, a registrant may:

  • Request to cancel a registration and receive a full refund, or
  • Request to transfer to a different class at no charge.
9 days-24 hours prior to the start date of the course:
  • Request to cancel a registration and receive 50% refund, or
  • Request to transfer to a different class and remit a $100 fee to process a transfer.
Less than 24 hours prior to the start of the course:
  • No withdrawals or transfers
  • Fee is non-refundable.

Substitutions (another person replacing a particular registrant in a course) are permitted at any time without additional charge.

Should DNV cancel a schedule course, our liability to course registrants is limited to the amount of the course fee. The registrant would then have the option of a full refund or transfer to an alternative available course (transfer fee is waived in this situation). We recommend that registrants wait until the course date is less than 30 days out before making travel arrangements.

**To register for a course, you may click the "location" link below to pay by credit card or you can contact us to pay by invoice. 

PLEASE NOTE: 

  • There will be a 10% administration processing fee for generating invoices. 
  • Discount codes are not applicable on invoiced orders.

Medical Device and Quality Management Training Courses

A management system that helps your company achieve business goals starts with quality training

2021 Public Training Calendar

ISO 13485:2016 Medical Device QMS Foundation

A must for those who will be auditing their own organization’s ISO 13485:2016 quality management system

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Learn the regulation requirements including the requirements for Technical Documentation and the Quality system

ISO 9001:2015 QMS Foundation & Internal Auditor

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ISO 9001:2015 QMS Auditor/Lead Auditor

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Effective Root Cause Analysis

Explores techniques for root cause analysis and suggests fitting applications of these tools

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High Level Leadership is a new 4-hour workshop designed specifically to address the needs of top management.