ISO 14971 an international standard for risk management related to the manufacturing of medical devices.It is recognized by most regulatory authorities as the “de facto” standard for risk management. ISO 14971 is an integral part of an effective quality management system and should be embedded into your medical device manufacturing life-cycle process. A solid risk assessment program helps you identify design issues before distribution, eliminating dangerous problems and the costs associated with recalls. 

Assessing your current compliance with ISO 14971:2019

ISO 14971:2019 was published December 2019.  Learn more about the updated ISO 14971.

Complying with ISO 14971 can be challenging. The standard requires you to review the risks posed by your devices over time and monitor any changes (e.g., design, customer input/feedback, and postmarket surveillance). This level of risk assessment calls for careful planning and appropriate staffing to support the necessary activities. Oriel STAT A MATRIX can help you develop and implement the needed processes efficiently and correctly while providing a valuable “outsider perspective” on your medical device risk management practices. The goal is to establish, document, and maintain a risk management process to:

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

Need to get smart about risk management in a hurry? Check out our intensive 3-day risk management training course. This class has been updated for ISO 14971:2019.

Recent regulatory changes make risk analysis priority #1   

Within the past few years, Europe has introduced the new Medical Device Regulation (EU MDR 2017/745) and an updated version of MEDDEV 2.7/1 revision 4, a guidance related to clinical data. The heightened importance of risk management to regulators is obvious and significantly impacts how you should approach risk analysis and planning for your medical devices. Failure to take this seriously can come back to bite you during a Notified Body audit or FDA inspection. 

Don't take chances – let our experienced team of ISO 14971 consultants assess your current medical device risk process

Future certification audits will be tougher and auditors will be looking more closely at your risk files and postmarket surveillance (PMS) data. Our consulting team has implemented hundreds of FDA GMP and ISO 13485 quality systems, and trained thousands of QA/RA professionals on risk management. Our team is skilled at identifying and reducing risk for all classes of devices, and they have extensive experience integrating ISO 14971:2019 into a new or existing  quality management system. We can:

• Plan an effective risk management program that works with your company’s business operations and establish processes to support the program.
• Identify hazards and estimate the probability that harm might occur.
• Estimate the severity of each hazard and evaluate the associated risks.
• Control risks and monitor the effectiveness of the controls put in place.
• Evaluate the risk posed by design changes as your device evolves.
• Integrate ISO 14971:2019 into your existing quality management system.

Our goal is to help you develop a system that will withstand an audit and enhance your overall quality, productivity, efficiency, and profitability.

Contact us today to learn how we can help you develop a fully compliant risk management program