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ISO 14971 Medical Devices Risk Management

MDD - The Medical Devices Directive

Risk-based thinking is essential for achieving effective medical devices to the market.

Now available in a travel-free LiveOnline classroom!

Risk-based thinking is essential for achieving effective medical devices to the market. ISO takes another step to improving your organization’s risks and opportunities profile through requirements spelled out in ISO 14971:2019 Medical devices — Application of risk management to medical devices.

This 2-day course explores new ISO requirements

  • Terms and definitions used for risk management of medical devices
  • Identification, evaluation and control of risks associated with the medical device as well as the processes for manufacturing the device
  • Device life-cycle stages
  • Establishing risk criteria.
  • Whether you are an ISO 13485 novice or an old pro looking to refresh your skills, this course is a must. 
Live Instructor-led Training; Virtual or On-site Classrooms To meet today’s high demand, constrained budgets, travel restrictions and personal safety, DNV GL now offers this training as both a LiveOnline (virtual) class. No travel needed. Take the course while at work or in your home office! You may also have the course presented on-site at your preferred location, pending travel advisories and restrictions.
Course Highlights:
  • An in-depth look at the core requirements found in ISO clauses 4 and 6 pertaining to identifying and addressing risks, opportunities
  • Using a risk-based approach to achieve management system objectives
  • Strategic planning exercises intended to aid in implementing effective management structures to promote sustainable business performance.

Who Should Attend: 
This course is highly recommended for anyone involved in auditing, designing, implementing, maintaining and/or improving a management system guided by the most popular ISO international standards.  

Recommended follow-up courses: 
ISO 13485:2016 Medical Device QMS Foundation, High Level Leadership, Root Cause Analysis and Problem Solving

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 GL 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.

Now available in a travel-free LiveOnline classroom!

Risk-based thinking is essential for achieving effective medical devices to the market. ISO takes another step to improving your organization’s risks and opportunities profile through requirements spelled out in ISO 14971:2019 Medical devices — Application of risk management to medical devices.

This 2-day course explores new ISO requirements

  • Terms and definitions used for risk management of medical devices
  • Identification, evaluation and control of risks associated with the medical device as well as the processes for manufacturing the device
  • Device life-cycle stages
  • Establishing risk criteria.
  • Whether you are an ISO 13485 novice or an old pro looking to refresh your skills, this course is a must. 
Live Instructor-led Training; Virtual or On-site Classrooms To meet today’s high demand, constrained budgets, travel restrictions and personal safety, DNV GL now offers this training as both a LiveOnline (virtual) class. No travel needed. Take the course while at work or in your home office! You may also have the course presented on-site at your preferred location, pending travel advisories and restrictions.
Course Highlights:
  • An in-depth look at the core requirements found in ISO clauses 4 and 6 pertaining to identifying and addressing risks, opportunities
  • Using a risk-based approach to achieve management system objectives
  • Strategic planning exercises intended to aid in implementing effective management structures to promote sustainable business performance.

Who Should Attend: 
This course is highly recommended for anyone involved in auditing, designing, implementing, maintaining and/or improving a management system guided by the most popular ISO international standards.  

Recommended follow-up courses: 
ISO 13485:2016 Medical Device QMS Foundation, High Level Leadership, Root Cause Analysis and Problem Solving

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 GL 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 14971 Medical Devices Risk Management

Risk-based thinking is essential for achieving effective medical devices to the market.

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

ISO 9001:2015 QMS Foundation & Internal Auditor

A must for those who will be auditing their organizations quality management system

ISO 9001:2015 QMS Auditor/Lead Auditor

Provides knowledge & skills needed to organize & lead a quality management system

Effective Root Cause Analysis

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

High Level Leadership

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