• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    MPO's Most-Read Stories This Week—July 2

    OmniGuide Awarded FDA Clearance for RevoLix Hybrid Thulium Laser

    Pancryos Forges License Agreement for Microencapsulation Device

    FDA Awards IDE Approval to SELUTION SLR Drug-Eluting Balloon

    Matt Rainville Joins Bigfoot Biomedical as Chief Commercial Officer
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Theranos Fraud Trial, Part II: The Blame Game Continues

    An Update on Surgical Robotics

    Letting the Light In: How Failure Analysis is the Cornerstone of Success

    Three Talent Strategies to Attract High-Demand Skills

    The Advantages of Bioburden Screening for Sterilization Validation
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Cirtec Medical

    Arthur G. Russell Co. Inc., The

    Concise Engineering

    Fusion Biotec Inc.

    Xact Wire EDM Corp.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    ‘Right to Repair’: Separating Fact from Fiction

    Taking a Holistic Approach to Decentralized Clinical Trials (DCTs)

    Investment in Health Startups Drops

    The Power of Leveraging Customer Relationships

    Cost Effective & Efficient Wire EDM Techniques
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Cirtec Medical

    Arthur G. Russell Co. Inc., The

    Concise Engineering

    Fusion Biotec Inc.

    Xact Wire EDM Corp.
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Columns

    Managing Risks for Medical Devices: A Guide to Understanding ISO 14971

    The intent of ISO 14971 is to provide a general “bird’s-eye view” approach to designing and implementing a risk management plan for medical devices.

    Managing Risks for Medical Devices:  A Guide to Understanding ISO 14971
    Related CONTENT
    • FDA Publishes 4 Draft Guidances in Continuing Effort to Modernize 510(k)
    • Semiconductor Industry Innovator Joins PrinterPrezz’s Board of Advisors
    • Understanding Food-Grade vs. Biocompatibility for Medical Device Materials
    • PrinterPrezz Announces ISO 13485:2016 Certification for 3D Printing of Medical Devices
    • 5 Lessons Learned: Avoiding the Quest Data Breach
    Helin Räägel, Ph.D., Biocompatibility Expert, Nelson Labs10.08.19
    Earlier this year, a final draft of the new ISO 14971: Medical devices— Application of risk management to medical devices came out for voting, and will soon be published as a revised document that will replace the current second edition of the document (ISO 14971:2007). This column will summarize the basic concepts of ISO 14971, highlight the main changes that were made to the document, and provide guidance on what to focus on when evaluating and documenting a medical device for its potential risks.

    The intent of ISO 14971 is to provide a general “bird’s-eye view” approach to designing and implementing a risk management plan for medical devices, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. The scope of the document is to assist medical device manufacturers in identifying the hazards associated with their medical device, estimate and evaluate the associated risks, control these risks, and monitor the effectiveness of the controls through design, production, and post-production phases to ensure patient safety throughout the duration of a product lifecycle. Although it is mainly targeted toward the medical device field, the highlighted methods and evaluation points can be effectively applied to a wider array of products not necessarily categorized as medical devices, making it a useful guide for all manufacturers.

    The first edition of ISO 14971 was released in 2000 to assist manufacturers, regulatory bodies, and healthcare providers with a framework to manage medical devices’ potential risks and provide a tool to actively improve the safety of medical devices. The second edition of ISO 14971 was developed and published in 2007 to address the need for additional guidance on the application of this standard and establish the relationship between hazards and hazardous situations that may arise during the use of a medical device. This third revision, due to be released soon, was developed with the intent of clarifying and describing in more detail some of the normative requirements such as risk management review and report, production, and post-production information that could and should be used for risk management and evaluation of overall residual risk—all essential to the risk management process.

    The term manufacturer, and who qualifies as a manufacturer as defined in ISO 14971, was updated in the new revision to include more examples to better identify the target audience for the document. In short, if a company is manufacturing a medical device or an accessory used with a medical device, or is remanufacturing or modifying an already existing medical device, or changing the intended use of the medical device, that party is considered to be a manufacturer from the perspective of ISO 14971 and should follow the guidance provided within the document.

    The main concepts for risk and risk management arise from the design and manufacture of a device, as well as from the intended use of that device. This means when evaluating for any risks associated with a given medical device, the circumstances of how it is made and how it is meant to be used become the most important aspects for risk evaluation. For instance, when a medical device is intended to be used on the surface of the skin (like an electro-conductive gel used for external muscle stimulation), the risks evaluated should only encompass the risks that are relevant to that specific intended use and not for a different application that is not clinically relevant.

    That said, the new guidance emphasizes the aspect of reasonably foreseeable misuse that should be taken into consideration when evaluating risks for a medical device. A reasonably foreseeable misuse is defined as either an intentional or unintentional use of a product or system in a way not intended by the manufacturer, but can result from readily predictable human behavior. For instance, if a medical device is intended to be carried inside a pocket or a purse, the risks for patient harm from a biocompatibility perspective are pretty much nonexistent. However, if it is known or could be anticipated that the device could be placed (despite recommendations) into contact with bare skin (such as inside a bra like some women do with their phones), the risk for this contact may increase several fold, and should be evaluated accordingly.

    When looking at the various risks for a given medical device and establishing the acceptance criteria for residual risks, you should always include a benefit-to-risk analysis that clearly outlines the pros and cons of using the device and identify the balance between the two opposing aspects. The new ISO 14971 emphasizes identifying the benefit a given medical device will bring. A benefit is defined in ISO documents as a positive impact or desirable outcome from the use of a medical device on the health of an individual, or a positive impact on patient management or public health. To identify the risks, the manufacturers are encouraged to think about all the characteristics that could affect the safety of their medical device and relate those back to the operating principle, intended use, and any reasonably foreseeable misuse of that given device. This systematic review can assist in identifying possible hazards and hazardous situations, and help in building effective risk management plans. Annex C of the document (former Annex D and F) provides a non-exhaustive list of possible hazards that can be associated with different medical devices, and provides a platform to start the evaluation of a new device or process.

    When talking about managing risk, another responsibility highlighted in the standard is that a manufacturer has to meet both pre-market and post-market requirements, such as adverse event reporting and notification of corrective actions. This data should be implemented in the risk management plan and the overall evaluation process. The new guidance provides examples of how to set up and implement risk control measures into the production and lifecycle of the medical device. It also highlights the effective use of design and process verifications that could serve as verification for the effectiveness of the risk control measures in the upfront manufacturing process. For example, a design verification process could establish the effectiveness of certain performance criteria on the device to minimize the risks down the line. In the new revision, a bigger push was made to emphasize the importance of using relevant data from post-market information and activities that could assist in reducing risks for the medical device. It is also mentioned that during the lifecycle of the product, valuable information could be received from various sources. Such information could come from the production process itself or through monitoring of the manufacturing process; it could be information generated during the installation, use and maintenance of the device, user information, or publicly available information. This data could even come from the supply chain and the so-called generally acknowledged state-of-the-art information. The information related to the generally acknowledged state-of-the-art can include new or revised standards, published validated data specific to the application of the medical device under consideration, the availability of alternative medical devices or therapies, and other information.

    It should also be mentioned that a companion document, ISO/TR 24971: Medical devices – Guidance on the application of ISO 14971 is also undergoing a revision to include the changes and updates associated with the revision of ISO 14971. ISO/TR 24971 is intended to provide more specific guidance to assist in the development, implementation, and maintenance of risk management for medical devices that aim to meet the requirements of ISO 14971. During the updating process, some of the informative Annexes that were previously included in the ISO 14971 were moved to ISO/TR 24971, including previous Annex D – Risk concepts applied to medical devices (risk severity evaluation), previous Annex G – Information on risk management techniques (risk management techniques), and previous Annex H – Guidance on risk management for in-vitro diagnostic medical devices.

    Overall, the main purpose of ISO 14971 is to provide a framework to develop and implement a risk management program for a medical device, or any device for that matter, that could be used by people. It highlights the need to use a risk-based approach to evaluate the potential risks for their actual clinical hazards, and guides the user of the standard through a thought process that, in the end, is intended to make the devices we use safer for the end-user. 


    Dr. Helin Räägel is an expert in biocompatibility, especially with respect to the relationship between medical device materials, biological systems, and the analytical procedures used to evaluate biocompatibility in-vitro and in vivo. She has over 10 years of experience in scientific research, over two years of medical device experience managing validation work for regulatory acceptance, and is currently working as a biocompatibility expert in the technical consulting group at Nelson Labs, giving guidance and recommendations for biocompatibility assessments targeted for regulatory submissions all over the world. Dr. Räägel received her Ph.D. in molecular cell biology, with research focusing on cell migration, polarity, and targeted delivery of bioactive therapeutics. Her postdoctoral research project aimed at discovering the molecular mechanisms behind organ development and structural assembly using in-vitro techniques and animal models. Her successful academic career was rewarded by an Alexander von Humboldt Fellowship in Germany and later by a Marie Curie Fellowship—research awards competitive on a global scale.
    Related Searches
    • validation
    • security
    • system
    • gel
    Related Knowledge Center
    • Testing
    Suggested For You
    FDA Publishes 4 Draft Guidances in Continuing Effort to Modernize 510(k) FDA Publishes 4 Draft Guidances in Continuing Effort to Modernize 510(k)
    Semiconductor Industry Innovator Joins PrinterPrezz’s Board of Advisors Semiconductor Industry Innovator Joins PrinterPrezz’s Board of Advisors
    Understanding Food-Grade vs. Biocompatibility for Medical Device Materials Understanding Food-Grade vs. Biocompatibility for Medical Device Materials
    PrinterPrezz Announces ISO 13485:2016 Certification for 3D Printing of Medical Devices PrinterPrezz Announces ISO 13485:2016 Certification for 3D Printing of Medical Devices
    5 Lessons Learned: Avoiding the Quest Data Breach 5 Lessons Learned: Avoiding the Quest Data Breach
    Turning a Regulatory Headache into a Competitive Advantage Turning a Regulatory Headache into a Competitive Advantage
    The Future of Medtech Manufacturing The Future of Medtech Manufacturing
    Selecting the Right Manufacturer to Ensure Reduced Sterilization Risk Selecting the Right Manufacturer to Ensure Reduced Sterilization Risk
    Precision Metal Components with Hobson & Motzer at BIOMEDevice Boston Precision Metal Components with Hobson & Motzer at BIOMEDevice Boston
    Micro Injection Molding with Accumold at BIOMEDevice Boston Micro Injection Molding with Accumold at BIOMEDevice Boston
    Laboratory Testing with Nelson Labs at BIOMEDevice Boston Laboratory Testing with Nelson Labs at BIOMEDevice Boston
    New Qosina White Paper Stresses Importance of Proper Risk Analysis Throughout Product Lifecycle New Qosina White Paper Stresses Importance of Proper Risk Analysis Throughout Product Lifecycle
    3D Printing Visionary Joins PrinterPrezz’s Board of Advisors 3D Printing Visionary Joins PrinterPrezz’s Board of Advisors
    The First 510(k) The First 510(k)
    Using Digitization to Get Ahead in Medtech Using Digitization to Get Ahead in Medtech

    Related Breaking News

    • FDA Publishes 4 Draft Guidances in Continuing Effort to Modernize 510(k)

      FDA Publishes 4 Draft Guidances in Continuing Effort to Modernize 510(k)

      FDA publishes draft guidance documents to provide device-specific performance criteria for the Safety and Performance Based Pathway.
      U.S. Food and Drug Administration 09.20.19

    • Semiconductor Industry Innovator Joins PrinterPrezz’s Board of Advisors

      Semiconductor Industry Innovator Joins PrinterPrezz’s Board of Advisors

      Newest board member served most recently as chairman and CEO of Ultratech Inc.
      Business Wire 08.27.19

    • Materials | Testing
      Understanding Food-Grade vs. Biocompatibility for Medical Device Materials

      Understanding Food-Grade vs. Biocompatibility for Medical Device Materials

      Just because a material is food-safe in no way implies it is also biocompatible.
      Dana Trousil, Medical NPI Team Lead, StarFish Medical 08.13.19


    • PrinterPrezz Announces ISO 13485:2016 Certification for 3D Printing of Medical Devices

      PrinterPrezz Announces ISO 13485:2016 Certification for 3D Printing of Medical Devices

      Certification represents an important milestone for the company that reflect its emphasis on safety and providing high-quality devices.
      Business Wire 08.07.19

    • Diagnostics | Software & IT
      5 Lessons Learned: Avoiding the Quest Data Breach

      5 Lessons Learned: Avoiding the Quest Data Breach

      Quest Diagnostics and LabCorp's recent security breaches stress the importance of taking third-party risk seriously.
      Jon Siegler, Chief Product Officer, LogicGate 07.29.19

    Loading, Please Wait..

    Trending
    • How To Overcome The Top 6 Medical Device Manufacturing Challenges
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • AI-Enabled SKOUT Device Improves Colorectal Cancer Screening
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • 7 Steps To Create Your Own Medical Device Marketing Plan
    Breaking News
    • MPO's Most-Read Stories This Week—July 2
    • OmniGuide Awarded FDA Clearance for RevoLix Hybrid Thulium Laser
    • Pancryos Forges License Agreement for Microencapsulation Device
    • FDA Awards IDE Approval to SELUTION SLR Drug-Eluting Balloon
    • Matt Rainville Joins Bigfoot Biomedical as Chief Commercial Officer
    View Breaking News >
    CURRENT ISSUE

    June 2022

    • OEMs Seek Molders Offering Timely Techniques
    • Robotic Surgery: Cutting Through to the Latest
    • Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Pharmavite Expands in Ohio with $200 Million Investment
    Nestlé Health Science Expands in New Zealand with Deal to Buy The Better Health Company
    Younger Consumers Drive Growing Demand for Ingestible Beauty and Skin Care Products
    Coatings World

    Latest Breaking News From Coatings World

    Azelis Acquires Chemical Partners, Strengthens Leadership in Africa and Middle East
    Emmanuelle Bromet Named Arkema Sustainable Development VP
    ROSS Planetary Dual Dispersers Have Unique Processing Flexibility
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most-Read Stories This Week—July 2
    OmniGuide Awarded FDA Clearance for RevoLix Hybrid Thulium Laser
    Pancryos Forges License Agreement for Microencapsulation Device
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Bayer Opens New Research and Innovation Center at Kendall Square
    Lonza Names Maria Soler Nunez as Head, Group Operations
    Eurofins DiscoverX Opens Shanghai Office
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Dexlevo Introduces Beauty Treatment technique, ‘GOURI’
    Revision Skincare Exec Wins Ernst & Young Entrepreneur of the Year
    Latest Updates About Cosmoprof North America
    Happi

    Latest Breaking News From Happi

    SCOTUS EPA Ruling Won’t Impact General Regulatory Authority
    Toning Collection For Zero-Brass Blondes is New at Colorproof
    Esthetician Studio Beauty Concepts Files Trademark Infringement Lawsuit Against Kim Kardashian and Coty, Inc.
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: Flint OPS, Xerox and MNYPIA Top This Week’s News
    Azelis Acquires Chemical Partners, Adds to Leadership in Africa and Middle East
    International Paper Publishes 2021 Sustainability Report
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    UPM Raflatac boosts operations in US, All4Labels returns to HP and more
    Fedrigoni Self-Adhesives to exhibit at Labelexpo Americas for first time
    CELAB Europe wins Paper Recycling award
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Weekly Recap: Lifetime Technical Achievement Award Presented to Richard Knowlson, Alkegen Completes Luyang Acquisition & More
    Glatfelter, Blue Ocean Closures Partner with Absolut
    What You’re Reading on Nonwovens-Industry.com
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—July 2
    NuVasive Inc. Opens Singapore Experience Center
    Pedicle Screw Systems Market to Top $3B in 2027
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: eMagin, Identiv, and Japan Display Top This Week’s Stories
    Epishine is Building a New Solar Cell Factory in Linköping, Sweden
    Toppan Establishes CVC Fund and Investment Management Company in the US

    Copyright © 2022 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login