Sterling Medical Devices & RBC Medical Innovations are combining to create Vantage MedTech! Meet RBC
Contact Us
Close Form

Interested in learning more about how we can work together in your current or next medical device design project?

Just fill out this form and we’ll be in touch!

  • This field is for validation purposes and should be left unchanged.

Wherever you are in your product development lifecycle,
Sterling can help.

P: 201-877-5682
F: 201-301-9169
info@sterlingmedicaldevices.com

ISO 14971

Author: Dan Sterling | Date: October 7, 2018

Considered the internationally accepted standard for the medical device industry, ISO 14971 is a guide for risk management of medical device manufacturing. Companies need to maintain explicit risk management policies and risk management plans, as well as training on the topics, while designing and developing products through their entire life cycle. There are two major co-dependent factors used in determining whether the risks the medical device poses are acceptable. On one axis there is probability of a hazardous event’s occurrence, or the likelihood of this event happening. On the other axis there is the evaluation of the severity of the event, or how risky the consequences are. In such cases where risk falls in an unacceptable range, there must be a review of the genuine benefit that comes with the continued permission of the residual risks. If found that the risk continues to remain unacceptable, steps for risk control must be taken to effectively mitigate or eliminate risk. ISO 14971 outlines this in a nine-part process of going through risk analysis, a risk evaluation, risk mitigations, and a residual risk analysis and management for medical device companies to prove risk management is accounted for in their reports. A digital copy of ISO 14971 (2007) has been made available online and can be viewed here.

Applications to Medical Device Risk Management

When dealing with high levels of investment as well as pioneering innovative ideals, regulations like ISO 14971 become a necessary factor in ensuring streamlined device design and development is safe—without unacceptable risk for all stakeholders involved. Original Equipment Manufacturers (OEMs) often overlook ISO 14971 with concerns the costs associated with risk factors are not justified and proceed to face a variety of complications that prevent their product from ever reaching production. Risk analysis of hazardous factors, like viruses or user inattentiveness, must be taken into account throughout the process of production and post-production, but especially so at the initial planning stages. This is to ensure solutions are met for possible risks early on which in turn lowers both potential monetary and time costs and sources of harm. Once to market, reliable ISO 14971 compliant risk management assures consumers that the industry approved product will provide a positive experience that is best suited for the nature of their intent. To learn more about risk management, read Sterling’s Risk Management page here.

Background Information

ISO 14971 is published by the International Organization for Standardization, commonly referred to as ISO. ISO is derived from the Greek word Isos, meaning “equal”. ISO 14791 was made to be a culmination of ISO/IEC Guide 51 and 63, with the most significant revision published in 2007 considered the most up to date standard, especially in comparison to FMEA which only focuses on failure analysis rather than risk management. Since 2013, there is now an advanced technical report known as ISO/TR 2491 to provide expert guidance on the applications of ISO 14971.

Share this!

Contact Us

  • This field is for validation purposes and should be left unchanged.

Resources

Alarm clock next to laptop on desk with bar graphs on screen

August 9, 2022

Using Regulatory Strategy to Reduce Medical Device Time to Market

Using Regulatory Strategy to Reduce Medical Device Time to Market According to recent estimates (1), the global medical device market is expected to grow from over $455 billion in 2021 to...
Read More >
View More Blogs
5 Mistakes Medical Device Startups Make

February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
Read More >
View More Videos
active drug delivery system

September 8, 2020

Implanted Drug Delivery System

Sterling Medical Devices designed and developed a Class III pain medication delivery system for patients with spinal injuries. The system is comprised of three devices: an implantable pump, a handheld Clinician Programmer, and a handheld Patient Therapy Controller. The pump is surgically implanted into the patient, and the two handheld devices each communicate with the pump when held within close proximity of it....
Read More >
View More Case Studies

Need help with your medical device?

Let Sterling Medical Devices show how to bring your idea from concept to prototype to
FDA/CE approval with a free custom project analysis.
Request Free Analysis