Risk Management Applied to Medical Devices (ISO 14971:2019)

Actions Panel

Early access

Risk Management Applied to Medical Devices (ISO 14971:2019)

Risk Management Applied to Medical Devices (ISO 14971:2019); June 15-16, 2023, 2-day online training

By GMED North America, Inc.

When and where

Date and time

June 15 · 7am - June 16 · 3pm PDT



Refund Policy

Contact the organizer to request a refund.
Eventbrite's fee is nonrefundable.

About this event

  • 1 day 8 hours
  • Mobile eTicket


Training Time: 2 full-day sessions: June 15, 10am - 6pm; June 16, 10am - 6pm EDT

Risk management goes beyond development and manufacturing; it is a vital part of all your company’s processes. ISO 14971 defines the international requirements of risk management systems for medical devices, defining best practices throughout the entire life cycle of a device.

To ensure your company gets a safe, effective product to market on time and within budget, you need a successful implementation of your risk management system.

With the newly updated ISO 14971:2019 standard, GMED North America has created a 2-day training session, to equip medical device manufacturers with the right understanding and implementation of the Risk Management for Medical Devices – ISO 14971:2019.


  • General knowledge of Risk Management for Medical Devices principles
  • Global knowledge of the European Medical device regulation: Directive 93/42/EEC and regulation (EU) 2017/745.


  • Regulatory Affairs Managers
  • Quality Managers
  • R&D and Manufacturing Managers
  • Internal and external Auditors


  • Know the standard’s vocabulary and principles
  • Understand the purpose, structure, and key concepts of ISO 14971
  • Know the risk management methodology for medical devices described in standard EN ISO 14971
  • Understand the risk management approach through regulation


  • Presentations
  • Practical working sessions
  • Course evaluation



  • Objectives of ISO 14971 standard and associated vocabulary
  • Standard General requirements
  • Standard Methodology (different steps)
  • Risk Management and usability
  • Risk Management within the EU Medical Device Regulation
  • ISO 13485 requirement – risk management approach
  • Practical working sessions
  • Group workshop
  • Course Evaluation
  • Summary and Discussion with the trainer

About the Trainer

Ibim Tariah, Senior Advisor Regulatory Strategy and Product Reviewer at GMED NA

Dr. Ibim Tariah is a Senior Advisor Regulatory Strategy and Product Reviewer at GMED North America. He graduated from the University of Manchester, U.K. with a doctorate degree in Materials Science with emphasis on polymer science and technology. Ibim previously worked at R&Q Solutions LLC as Vice President, EU MDR & IVDR Services providing leadership, strategic advisement, and was previously the Technical Director at BSI where he worked for 21 years.

As a Senior Advisor Regulatory Strategy and Product Reviewer, Ibim is responsible for Regulatory Strategy development activities and implementation, including liaison with both GMED HQ and other Regulatory Agencies and provide expertise to support GMED Commercial, Technical & Regulatory Compliance activities.

About the organizer

 GMED North America. is the subsidiary of GMED, leading Certification Organization & distinguished Notified Body (CE0459).

GMED is a leading Certification Organization and a distinguished Notified Body (CE0459) whose scope covers all of the existing European Medical Device Directives (90/385/EEC, 93/42/EEC and 98/79/EC).


GMED is also an Auditing Organization Recognized by the MDSAP Regulatory Authority Council and has been performing MDSAP audits since April 2015. GMED is accredited under the NF EN IEC/ISO 17021-1:2015 standard by COFRAC (Certificate № 4-0608), the French Accreditation Committee, to carry out Quality Management System Certification activities according to ISO 9001:2015 and ISO 13485:2016. 


Established in 1994, GMED is fully owned by LNE (e.1901), a State owned Industrial and Commercial Establishment (EPIC), and operates since August 1st, 2018 as a simplified joint stock company (SAS) within the LNE group. 


GMED’s success and high level of performance rely first and foremost on a strong and dedicated team of individuals trained at the highest level of the current evaluation and auditing methods to provide the best certification services: Certification Project Managers, Subject Matters Specialists (MDAO or Medical Device Animal Origin, Medicinal Substance, Active Implantable Medical Devices, Microbiologists), Technical Documentation Evaluators and Design Dossier Assessors, Clinical Reviewers & Experts (Ex: Sterilization Methods and Validation) and Auditors for CE marking and QMS activities. 


With offices in Europe and a dedicated US Operation created in 2005 - GMED North America (MD), GMED offers the convenience and efficiency of local teams of experimented specialists to accompany your certification process which will allow you to market in your target markets.