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ISO 14971:2007 (Risk Assessment to Medical Device)

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This ISO 14971:2007 (Risk Assessment to Medical Device) training course is a 1 Day public programme, designed to provide attendees with an understanding of the impact that ISO 14971 has on the decision making process at medical device manufacturing firms.

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Course Content:

  • Introduction & Course Objectives
  • Risk Management
    • Why Risk Management
    • Understand the need for risk management
    • Understand the regulations pertaining to risk management
  • Introduction to ISO 14971– Risk Management (Medical Devices):
    • Structure of the standard – Medical Devices
    • Requirements of the standard
    • Contents and purpose of each section
    • Correspondence to and differences between ISO 9001:2000
    • CE marking implications
  • The Process:
    • Risk Management Process
    • Understanding the characteristics related to devices
    • Identifying possible hazards
    • Estimating the associated risk
    • Review & reduction of risk
  • Risk Management / Assessment Techniques:
    • Risk Management using FMEA
    • Risk Management using FMECA
    • Risk Management using Fault Tree Analysis
  • Audit Exercise using the standard:
    • Attendees will break into groups and carry out an FMEA of specific areas
    • Afterwards the groups will convene to share experience
    • Conclusions
    • Responding to an Audit
  • Q&A
  • Conclude & Follow Up Process

This ISO 14971:2007 (Risk Assessment to Medical Device) training programme may be beneficial to Management, Product Design Managers, Engineers, Process Owners, QA and Regulatory personnel in the medical device field. It builds a strong foundation for those new to risk management standard and it provides a concise refresher to people experienced in the regulatory field.

Classroom based, instructor lead, practical hands on course.

Product Description

This ISO 14971:2007 (Risk Assessment to Medical Device) training course is a 1 Day public programme, designed to provide attendees with an understanding of the impact that ISO 14971 has on the decision making process at medical device manufacturing firms.

Awarding Body: Optima Training & Consulting Ltd

National Framework of Qualifications Level: N/a

Certification: Optima Training & Consulting Ltd Certificate of Completion

Renewal: N/a

Entry Requirements:
Minimum age- 18 years old

Minimum English requirements: Leaners must be able to understand and convey the concepts contained in the programme content.

Assessment Details: Class Interaction

Cost Per Person:
The fee is inclusive of all training courseware materials, certificate of completion and 3 months after training support.

Progression Opportunities: Please see related courses

Protection for Enrolled Students: N/A

Should a course not proceed, any payment received will be refunded within 48 hours