Medical Device Quality Risk Management – ISO 14971

This introductory course covers the key concepts of ISO 14971:2007 and how to apply the standard.

As stated in the standard:

“This International Standard specifies a process through which the manufacturer of a medical device can identify hazards associated with a medical device, estimate and evaluate the risks associated with these hazards, control these risks, and monitor the effectiveness of that control.”

Course Duration & Location

1-3 days, on your site or at one of our training centers.

CiPharma’s training courses can be delivered anywhere in the world. If your site is not in a city we have an office in then we ask you to cover the travel costs from our nearest office. You’ll save the costs associated with your staff traveling to be trained, so it becomes cost effective if you have several people needing training.

The following topics are covered in the course:

Preliminary Hazard Analysis (PHA)

PHA is an inductive method of risk analysis with the aim of identifying any hazards, hazardous situations and events that can cause harm for a given process, facility or system. Most commonly practised in the early stages of project development when design detail may be lacking. Considers materials, equipment and operating environment variables among others.

Fault Tree Analysis (FTA)

A ‘top down’ approach to hazard analysis. Starting at a top event, FTA uses a deductive process and a stepwise identification of undesirable system operation to reduce risk. A simple method that uses diagrammatic representation of processes for people to quickly and effectively estimate and control risk.

Failure Modes Effect Analysis (FMEA)

The “what happens if…” approach. A method that analyses one line item at a time and is a bottom up approach that seeks to control risk at the next functional level to original risk identification.

Hazard and Operability Study (HAZOP)

HAZOP is based on a theory that assumes accidents are caused by deviations from the design or operating intentions. Team based approach that is similar to FMEA in its interpretation and analysis of risk.

Hazard Analysis Critical Control Point (HACCP)

HACCP is a commonly used risk management model that focuses on the control and monitoring of initiating risk factors that cause product hazards originating in manufacturing processes in particular.

Upon completion of this course participants will be able to;

Course Duration & Location

3-5 days, on your site or at one of our training centers.

CiPharma’s training courses can be delivered anywhere in the world. If your site is not in a city we have an office in then we ask you to cover the travel costs from our nearest office. You’ll save the costs associated with your staff travelling to be trained, so it becomes cost effective if you have several people needing training.

What you will learn

  • Know key features of various Risk models including, FMEA, FMECA, HAZOP and HACCP
  • Understand what regulators will expect in Quality Risk Management policies, procedures and justification documents
  • Completely understand the ISO14971-2007 Standard
  • Understand ISO14971 and ICHQ9 and the relationship between these key documents
  • Understand the critical processes of Quality Risk Management in a Medical Device context
  • Understand how Risk Management can improve your company’s bottom line
  • Discuss Risk Management compliance requirements
  • Course materials

    Participants will receive a copy of the presentation(s), relevant notes and workshop materials.

    A certificate of completion will be issued to participants who successfully complete the assessment.

    Assessment

    A written assessment is conducted at the end of the course.

    Course Format

    The course is a combination of lecture-style learning and active workshops with participants working in small groups on assigned tasks.

    Who should attend?

  • Quality Assurance personnel
  • Quality Control personnel
  • Operations or Manufacturing personnel
  • Validation personnel