Risk Management for the Medical Device Industry: 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.
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?
Medical device manufacturers meeting the ISO 14971 standard must establish and document a process that identifies hazards, estimates and evaluates the severity of risks, controls risks and monitors the effectiveness of those controls throughout the product’s lifecycle.
The 7 core elements of the standard’s requirements include:
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.
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?
Based on probability and severity of risk uncovered during risk analysis, is the risk acceptable?
Risk control is the implementation of measures to reduce risk and harm of identified hazards.
Overall Residual Risk Acceptability
After implementing Risk Controls, residual risk is re-evaluated at this stage.
Risk Management Review
The Risk Management Report should summarize all risk management activities and analyses and describe the overall risk acceptability.
Production & Post-Production Activities
Requires the manufacturer to document and maintain a system to collect and review information about the medical device 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 using and provides a simpler method of comparing competitor devices, trending adverse event reports and recalls, as well as benchmarking your products against industry averages.
Navigator can assist in 4 areas of the ISO 14971 standard:
Navigator has the ability to reveal the top device problems for a specific product against industry averages.
Navigator makes it easy to identify similar devices and analyze their risks.
Estimation of the risk(s) for each 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.
Navigator helps assess the severity of risk and informs your own judgement of the risk’s acceptability.
Production and post-production information
Navigator was made for post market surveillance and 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 a 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.