TRAINING CATEGORIES
(Click Category to List Courses)

28 - ISO - ISO (Standardization) Programs


ISO 120 - ISO 14971: Risk Management of Medical Devices

Code Start Date Duration Venue
ISO 120 25 November 2024 5 Days Istanbul Registration Form Link
ISO 120 16 December 2024 5 Days Istanbul Registration Form Link
Please contact us for fees

 

Course Description

On completion of this course the participant will learn why the risk management process is important, the general requirements of a risk management system and how to perform a risk analysis and control risk in an organisation. ISO 14971 specifies a process for a manufacturer to identify the hazards associated with medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971 are applicable to all stages of the life­cycle of a medical device. This course helps medical device professionals understand how ISO14971 can improve their business and risk management efforts. The student will gain an understanding of the impact that ISO14971 has on the decision making process when manufacturing medical devices. After finishing the course, the student will gain the ability to work with risk management for medical devices according to the ISO 14971 standard.

Course Objectives

  • Identifying the links between ISO 13485 (QMS) and ISO 14971 (RM)
  • Explaining how risk management relates to the product lifecycle
  • Defining risk management terminology
  • Outlining the stages of the risk management process
  • Defining the key deliverables of the risk management process

Who Should Attend?

  • Regulatory, quality, design (including design changes), development, manufacturing, marketing managers and personnel.
  • Decision makers on management system strategy
  • Internal auditors
  • Executive managers
  • Business continuity management practitioners
  • Those involved in the design, implementation and management of medical device safety management system.

Course Details/Schedule

Day 1

  • Introduction to risk management in medical devices
  • Links of risk management to regulatory requirements
  • The relationship of ISO14971 to other standards
  • ISO13485 and Risk Management
  • Understanding ISO13485

Day 2

  • The development of ISO14971
  • Why do we risk manage medical devices using ISO14971?
  • The Lifecycle approach
  • ISO14971 – Overview of the standard
  • Terms and definitions
  • General requirements of the standard

Day 3

  • The risk management process
  • The risk management plan
  • Risk analysis
  • Risk evaluation
  • Risk control

Day 4

  • Residual risk acceptability
  • Report/documentation
  • The Risk Management File Post­production
  • IEC 60601­1:2005: Medical Electrical Equipment, General requirements for basic safety and essential performance

Day 5

  • Tools for Risk management
  • Failure modes and effect analysis
  • Fault tree analysis
  • Hazard analysis and critical control point
  • Summary and conclusions

 

ETABS and SAFE. Training 24 CCE 210 5 SAP 2000. Training 25 CCE 305 5 Quality Assurance in Pavement Construction 26 CCE 401 5 Construction Project Management 27 CCE 402 10 Construction Project Management (10 Days) 28 CCE 403 5 Construction Project Management-Intensive 29 CCE 405 5 Principles of Construction Project Management 30 CCE 406 10 Principles of Construction Project Management (10 Days) 31 CCE 410 10 Construction Project and Risk Management (10 days) 32 CCE 411 5 Project & Contract Management for Marine Construction 33 CCE 412 5 Application of GIS in Construction Management 34 CCE 415 4 Sustainable Water Management Techniques, Innovation and Solution (4 Days) 35 CCE 419 5 Construction Management of Hydraulic Projects 36 CCE 420 5 Water Project Management 37 CCE 421 10 Modern Technologies in the Supervision and Quality Control of Irrigation Projects and Dealing with Contractors (10 Days) 38 CCE 422 5 Rapid Earthquake Hazard Evaluation of Buildings 39 CCE 425 10 Practical Application of Computers in Structural Engineering (10 Days) 40 CCE 428 5 Survey & Profile Using Total Station 41 CCE 430 5 Bridge Construction and Maintenance 42 CCE 435 5 Bridge Inspection and Maintenance 43 CCE-A 410 10 إدارة المشاريع الهندسية -10 أيام
21 - TTC - Transportation and Traffic Control
22 - ADV - Architectural Design and Visualization
23 - SRM - Safety and Occupational Health
24 - CSM - Public Relations, Communication Skills & Office Management
25 - TEM - Training and Education Management
26 - CMR - Customer Relations