ISO 14971 Certification: Risk Management System For Medical Devices

› What is ISO 14971 Certification?

› How To Process ISO 14971 Certification?

› What are the advantages ISO 14971 Certifications?

› How Much cost of ISO 14971 Certification?

› How to Audit of ISO 14971 standard Certification?



› How do I select a ISO Certification body for ISO 14971 standard?

› Where can I compare ISO 14971 products and Certification training?

ISO 14971 Certification

In 2000 year, the primary edition of ISO 14971 Certification was released because the international standard for risk management of medical devices. This year, the ISO technical committee (ISO/TC 210) has been working diligently refreshing this comprehensively perceived standard. And while the elemental stages of the danger management process remain unchanged, there are some key modifications that medical device manufacturers should remember of to make sure that they will successfully navigate the event , testing, and launching of latest products within the coming years.

The most significant revisions include the following:

  • 3 new definitions are being introduced (benefit, reasonably foreseeable misuse & state of the art)
    • Advantage-risk analysis is being refocused to align the concept with terminology utilized in other major regulations, like the EU MDR
    • Additional emphasis on the scope of the ISO 14971 Certification risk management process; for instance , all risks related to a medical device, starting from electrical to usability and information security
    • More emphasis is being placed on the importance of risk management planning by explicitly requiring that proper execution of the plan is verified during risk management audit.
  • Risk management plans must define the methods and criteria wont to evaluate acceptability of the general residual risk.
  • The various requirements to disclose certain residual risks are being merged into one requirement as a part of the “Evaluation of overall residual risk”.
  • Risk management requirements for proactive production and process-based post-production activities are elaborated upon and restructured

The third version of ISO 14971:2019 Certification was at long last discharged in December 2019 and it replaces ISO 14971:2007.

Overall, no tectonic shifts have occurred – the danger management process itself remains largely unchanged. Nonetheless, there are important clarifications and updates in ISO 14971:2019 that you simply should remember of. In reviewing the new ISO 14971 Certification, pay particular attention to the highlighted sections below.


One big change – . Annex B of the quality contains a useful guide for comparing clauses within the second and third editions.

Three important definitions are added to the new ISO 14971:2019 Certification and are noted below.

Other minor changes were made to the subsequent terms: accompanying documentation, harm, IVD, manufacturer, and use error. make certain to audit those.

  • Reasonably foreseeable misuse: The new definition states that if misuse of a product may result from “predictable human behavior” then you would like to require this under consideration in your risk analysis. “Reasonably foreseeable” are often unintentional or intentional and includes those “why -in-the-world would-someone-do-that” scenarios. This analysis applies to get users and professional users.
  • Benefit : It’s not surprising that a typical focused on risk would neglect to define “benefits.” This term wasn’t defined in ISO 14971:2007 or EN ISO 14971:2012, but it’s addressed within the third edition. The definition now aligns with terminology utilized in many regulations. See more on this below.
  • State of the art: This perplexing term appears 12 times within the EU MDR and 20 times within the IVDR but isn’t defined in either regulation! ISO 14971:2019 Certification helps settle the issue by obtaining the recently stamped definition found in ISO/IEC Guide 63:2019.

That guide defines state of the art as: “Developed stage of technical capability at a given time as regards products, processes and services, supported the relevant consolidated findings of science, advancement and data.” in that particular condition, ISO 14971 Certification might be considered the “forefront” whenever it incorporates chance organization for medical devices.

Benefits Of Implementing ISO 14971 Certification :

  1. Implement ideal methods of reducing risk for all stakeholder.
  2. Develop devices and therapies that are proven effective within the industry.
  3. Manage speed and price to plug.
  4. Optimize speed of iteration.
  5. Streamline the regulatory process which will enable entry to chose markets.

How to Get ISO 14971 Certification Easily ?

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