0345 600 6975enquiries@qualitation.co.uk
  • F.A.Q
ISO Standards
SEARCH
Qualitation - ISO ConsultancyQualitation - ISO Consultancy
Qualitation – ISO Consultancy
The British Quality Centre
  • HOME
  • What we do
    • ISO Standards Services…
      • Advice – Deciding if ISO Standards are right for you
      • Design, Creation and Installation of Standards
      • Internal Audit Assistance
      • Management Reviews
      • Rescue Service
      • Pre-Assessment Reviews
      • Post-Assessment Assistance
    • ISO STANDARDS Available…
      • Quality+…
        • ISO 9001
        • ISO 14001
        • ISO 45001
      • Aviation Space & Defence…
        • AS 9100 Series
        • AS 9100
        • AS 9110
        • AS 9120
      • Automotive
        • ISO / TS 16949 Automotive
      • Laboratory & Medical…
        • Medical Devices CE Marking
        • ISO 13485
        • ISO 14791
        • ISO 17025
        • ISO 15189
      • IT and Information Security ISO Certification…
        • ISO 27001
        • Cyber Essentials
    • GROWTH AND EFFICIENCY…
      • Lean Management
      • Six Sigma
      • Team Building
      • Productivity
      • Psychological Testing
      • Change Management
    • ISO IT Business Systems…
      • Document Control & Authorisation Process
      • Internal Audit Control Process
      • Staff Training Control and Virtual Training Process
      • Key Performance Indicator Monitoring
      • Board Goal Attainment Measures
  • FREE TOOL
  • Training Courses
  • ABOUT
    • About Us
  • ARTICLES
  • CONTACT
Menu back  

ISO 14791

Medical Devices Risk Management

ISO 14791 Medical Devices Risk Management

This standard details terminology, principles and a process for risk management of medical devices, including software when it is used as a medical device and also in-vitro diagnostic medical devices.

The approach described in this document is written to help the makers of medical devices to identify the hazards involved with the medical device, to assess the associated risks, to control these risks, and to check up on those controls subsequently.

The standard’s requirements apply to each part of the life cycle of a medical device. It specifically relates to risks associated with a medical device, such as those linked to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.

These processes can also be applied to non medical devices in some jurisdictions and circumstances and can also be used by others involved in the medical device life cycle.

This standard requires manufacturers to create objective criteria for risk acceptability but does not specify acceptable risk levels – which is left to the determination and business judgement of the manufacturer.

Risk management should be an integral part of any quality management system. However, this document does not require the manufacturer to have a formal quality management system in place.

Specifically, ISO 14971 is a nine-part standard which first establishes a framework for risk analysis, evaluation, control, and review, and also specifies a procedure for review and monitoring during production and post-production.

ISO 15189, Medical Laboratory Competence, qualitation

Typical sections include:

A) Inherent safety by design

For example:

  • Use specific connectors that cannot be connected to the wrong component.
  • Remove features that can be mistakenly selected or eliminate an interaction when it could lead to use error.
  • Improve the detectability or readability of controls, labels, and displays.
  • Automate device functions that are prone to use error when users perform the task manually.[10]

B) Protective measures in the medical device itself or in the manufacturing process

For example:

  • Incorporate safety mechanisms such as physical safety guards, shielded elements, or software or hardware interlocks.
  • Include warning screens to advise the user of essential conditions that should exist prior to proceeding with device use, such as specific data entry.
  • Use alerts for hazardous conditions, such as a “low battery” alert when an unexpected loss of the device’s operation could cause harm or death.
  • Use device technologies that require less maintenance or are “maintenance free.”

C) Information for safety

For example:

  • Provide written information, such as warning or caution statements in the user manual that highlight and clearly discuss the use-related hazard.
  • Train users to avoid user-related errors.

 

To find out more, please contact us below:

Meet a Qualitator

    Contact Us and let our Qualitators take the load from your mind!

    Contact a Qualitator

    Call: 0345 600 6975

    Email: enquiries@qualitation.co.uk

    Choose your ISO
    • Why Put Quality First?
      29th May 2019
    • Why Should Quality Matter More To Your Business?
      21st May 2019
    • ISO Standards Support Key Business Priorities for 2018
      20th January 2018
    • How ISO Certification Influences Consumer Choice
      28th July 2017
    • Your Options on How to Get ISO 9001
      19th May 2017
    • ISO 17025 For Forensic Laboratories
      28th April 2017
    Case Studies
    • Anite Telecoms – 17025 GAP Analysis
      9th December 2015
    • Portsmouth Water – ISO17025
      27th August 2015
    • Qualitation, ISO Certficiation
      KP Acoustics – ISO17025
      20th August 2015
    Qualitation
    CONTACT

    Telephone: 0345 600 6975
    Reg. Office: 66 Elms Drive, Oxford, OX3 0NL
    VAT 150 9855 91

    Find us on:

    LinkedinMail
    Membership
    • bsi
    • tub
    • lrqa
    • cqi
    • bab
    © 2015-2020 Qualitation | Reg'd in England and Wales | No. 08265550
    Qualitation is a trading name of Oxford Quality Centre Ltd | Privacy policy
    We use cookies to give you the best online experience. By using our website you agree to our use of cookies in accordance with our cookie policy.