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ISO 14971 Risk Management Consulting for Medical Device Companies

ANSWERED ON THIS PAGE:

  • What is ISO 14971 and where is it recognized?
  • How will risk/benefit analysis benefit my company?
  • What are the steps in the ISO 14971 implementation process?

ISO 14971 is an international standard for risk management of medical devices. It is recognized by the US Food and Drug Administration (FDA), European authorities, Health Canada, the Australia Therapeutic Goods Administration and other regulators as the "de facto" standard for risk management of medical devices. ISO 14971 is an integral part of a quality system and should be incorporated into the life cycle process of medical devices.

What is the purpose of ISO 14971?

ISO 14971 helps your company establish, document, and maintain a risk management process to:

  • Review the intended use of the medical device.
  • Identify hazards and estimate the probability that harm might occur.
  • Estimate the severity of each hazard and evaluate the associated risks.
  • Control those risks and monitor the effectiveness of the controls put in place.

This standard requires a review of the product's risk assessment over time to monitor any changes - from design changes to customer input/feedback, including post market surveillance. This can be done during management reviews and should also be part of your internal audit process. Risk assessments need to state the frequency of the review and the data that will be reviewed.

To learn more about medical device risk/benefit analysis, download our 9-page white paper.

How do you implement ISO 14971?

Many medical device companies find adopting ISO 14971 a challenge. But if you are in the process of implementing an ISO 13485 quality management system, we can assist with integrating ISO 14971 with your existing quality management system. Our implementation process has two parts:

  • Step One: Gap Analysis

Our expert consultants perform an on-site or off-site review of your current procedures and risk management documents to analyze your current level of compliance with the standard.

  • Step Two: Establish Risk Management process and Risk Management File

Based on our gap analysis and requirements for your device type, we design and document a system for managing and evaluating risk that meets the requirements for ISO 14971.

Why choose Emergo as your ISO 14971 consultants for medical device risk management:

Emergo's global team of QA/RA consultants can help you assess your quality system, implement ISO 14971, and comply with risk management requirements in markets around the world. Here's what you get when you choose Emergo:

  • Our consulting team has implemented hundreds of FDA QSR and ISO 13485 quality systems at medical device companies making a wide range of Class I, II and III devices.
  • Our experienced team of consultants is skilled at identifying and reducing risk in all types of devices and processes.
  • We have extensive experience integrating EN ISO 14971:2012 into existing ISO 13485 and FDA GMP quality management systems.
  • Emergo is widely known in the industry for providing high quality consulting to medical device companies.

We specialize in quality assurance and ISO 14971 compliance for medical device and IVD companies.

Ask us for detailed information about ISO 14971 consulting services.

Learn about the process, costs and timelines.

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Common questions

How do we maintain compliance with ISO 14971?
Emergo's QA consultants can train your employees and management on the benefits and processes of ISO 14971 compliance. Learn more about our risk management training.

 

Within the UL family of companies we provide a broad portfolio of offerings to all the Medical Device industries.  This includes certification, notified body and consultancy services In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our Brand and our customers brands UL is unable to provide consultancy services to Notified Body or MDSAP customers.  UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Read more about this.