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ISO 14971 is a standard for the application of risk management methods for the safe use of medical devices throughout their life-cycle. ISO 13485 Clause 7.1, Planning for product realization states that: 'Further information can be found in ISO 14971'. This means that the use of ISO 14971 is not mandatory.

To maximize effectiveness of your risk management system, ISO 14971 can and should be an integral part of your quality management system (QMS) as required by ISO 13485. Specific requirements of ISO 14971 include: Provision of adequate resources. Assignment of qualified personnel.

ISO 13485 requires risk-based thinking regarding QMS processes (sub-clause 4.1. 2) and risk management with regard to patient/end-user safety in using the medical device (clause 7.1).

ISO 13485 (3rd Edition).

ISO 14971, recognized worldwide by regulators, is widely acknowledged as the principal standard to use when performing medical device risk management. IEC 62304:2006, makes a normative reference to ISO 14971 requiring its use.

What is the difference between ISO 13485 and ISO 14971? ISO 13485 focuses on quality and customer requirements for medical devices, whereas ISO 14971 focuses primarily on safety, security, and risk associated with the use of medical devices.

The ISO 24971 provides different inputs that can be used as starting point for the evaluation of the residual risks, for examples: Different sequences of events can lead to different hazardous situations and risks, each contributing to the overall residual risk.

Risk per ISO 14971 is defined as the combination of the probability of occurrence of harm and the severity of that harm. The intent behind Risk Management is to identify, evaluate, analyze, assess, and mitigate potential product issues. Risk Management is a total product life cycle process.

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© Copyright 1997-2025
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232