This site uses modern web standards that aren't supported by your browser. For best results, please upgrade to Google Chrome, Microsoft Edge, or Mozilla Firefox.

The 7 core elements of ISO 14971

|

Reed Tech Navigator for Medical Devices

Risk Management for medical devices — what is ISO 14971?

ISO 14971 is an international standard that describes a systematic approach for medical device risk management. ISO 14971 has been recognized as a consensus standard by most regulatory agencies around the world including the U.S. FDA, Health Canada, and the European Union Competent Authority.

There are currently two versions of the standard, ISO 14971:2007 and EN ISO 14971:2012. The 2012 version applies specifically to manufacturers who produce medical devices to be sold in the European market, while the 2007 version remains as the standard for the rest of the world. The two standards are the same with the exception of additional annexes in the 2012 version that are harmonized to comply with European Union medical device regulations. Both versions of the regulatory requirement ensure medical devices worldwide are as safe as they are effective.

How does ISO 14971:2007 intersect with FDA regulation?

The FDA’s Quality System Regulation, specified in the design controls section of 21 CFR 820.30, requires medical device manufacturers to take a total lifecycle approach to risk management as a part of their quality management system. Implementing a quality management system that utilizes the FDA-recognized ISO 14971 standard may help to streamline compliance with the design controls regulation as well as enforcement decisions by the FDA.

What does the ISO 14971:2007 standard require?

The ISO 14971 monitors and evaluates risks at every stage of a medical device’s usage. Medical device manufacturers meeting the ISO 14971 standard must establish and document a process that identifies hazards (any potential sources of harm), estimates and evaluates the severity of potential risks, controls risk threats, and monitors the effectiveness of those controls throughout the product’s lifecycle. Risks are defined by e a combination of the probability that harm will occur and the severity of that harm.

There are currently two versions of the standard, ISO 14971:2007 and EN ISO 14971:2012. The 2012 version applies specifically to manufacturers who produce medical devices to be sold in the European market, while the 2007 version remains as the standard for the rest of the world. The two standards are the same with the exception of additional annexes in the 2012 version that are harmonized to comply with European Union medical device regulations. Both versions of the regulatory requirement ensure medical devices worldwide are as safe as they are effective. 

The 7 core elements of the standard’s requirements include:

1. Risk Management Planning The Risk Management Plan is a product-level document that should identify and include all risk management activities anticipated and planned throughout the product’s lifecycle. Think about every use-case and every potential situation the product may be in to evaluate all situational risks.
   
2. Risk Analysis Risk analysis requires manufacturers to identify possible hazards for a device. For those hazards, what is the probability of occurrence of harm and the severity of that harm? Things like possible physical damage, injury to patient health, or dame to the environment, or property must be considered.
   
3. Risk Evaluation Based on the probability and severity of risk uncovered during risk analysis, is the risk acceptable? Does the likelihood outweigh potential severity? Risk Evaluation is the step where the balance is determined.
   
4. Risk Control Risk control is the implementation of measures to reduce the risk and harm of identified hazards. Any precautions are taken to avoid hazards that affect any stage of the device’s operation can be considered risk control.
   
5. Overall Residual Risk Acceptability After implementing Risk Control, residual risk is re-evaluated at this stage. Are measures taken to make a difference and how much difference? Overall residual risk acceptability is the point where risks can be resolved as acceptable, because they are unlikely to occur or cause severe consequences.
   
6. Risk Management Review The Risk Management Review report should summarize all risk management activities and analyses and describe the overall risk acceptability. This document summarizes the entire process.
   
7. Production & Post-Production Activities Production and Post-Production Activities require the manufacturer to document and maintain a system to collect and review information about the medical device. Evaluation should be done in both production and post-production phases.

How can Reed Tech help with ISO 14971 compliance?

Reed Tech Navigator for Medical Devices™ was created to help identify hazards and assess their risks per ISO 14971 requirements. Navigator is an easy-to-use solution that enhances the internal data you are currently applying and provides a simpler method of comparing competitor devices, monitoring trends of adverse event reports and recalls, and benchmarking your products against industry averages.

Navigator can assist in 4 areas of the ISO 14971 standard:

Risk analysis
Risk can be tricky to judge correctly. With so many interpretations of each concern, perspective can affect the analysis. Instead, let the data do the work. Navigator has the ability to reveal the top device problems for a specific product against industry averages.
Navigator also makes it easy to identify similar devices and analyze their risks.

Estimation of the risk(s) for each hazardous situation
If people, property, or the environment are exposed to one or more hazard(s), it is considered to be a hazardous situation. Navigator can show you how often a device problem was reported, and the severity (death, injury, or malfunction), as well as reported patient problems.

Risk evaluation
Navigator helps assess the severity of risk and informs your judgement of the risk’s acceptability.

Production and post-production information
Navigator was made for post-market surveillance; It can help you trend and benchmark safety risks, maintain a data-driven risk matrix and be alerted to new safety risks for your product or a competitor product.

If you are looking for an effective new way to monitor safety and quality data for medical devices, look into the power of Reed Tech Navigator. Along with basic product searches, users can activate Product Alerts to receive email notifications whenever product events are reported. By setting a Product Alert for any products you have added to a Watchlist, you will be among the first to know if your device or a competing device may be subject to a reported hazard or risk.

Post-market surveillance is just one of the many ways Navigator streamlines device safety and quality research. If you’d like to see how it can help you, contact Reed Tech today.

Get a Two-Day Trial

By continuing to use the site, you agree to the use of cookies. more information

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.

Close