Medical Device Risk Management

The Importance of Medical Device Risk Management

From design, to engineering, to testing, and beyond, your medical device risk management process is an integral part for every phase of the project. Whether you are seeking to design a new product or improve an existing one, your medical device risk management process must be rigorous; especially if you are trying to gain FDA & CE approval.

If your medical device risk management process is not done correctly, this can lead to your project lacking certain mitigations. This not only affects your budget and increases time to market, but if found late in the process you may be required to redesign, redevelop, and retest your device throwing your project off the rails. Since having these mitigations and good practices are core to the FDA & CE approval process, you need a diligent medical device risk management process.

The Importance of Medical Device Risk Management

From design, to engineering, to testing, and beyond, your medical device risk management process is an integral part for every phase of the project. Whether you are seeking to design a new product or improve an existing one, your medical device risk management process must be rigorous; especially if you are trying to gain FDA & CE approval.

If your medical device risk management process is not done correctly, this can lead to your project lacking certain mitigations. This not only affects your budget and increases time to market, but if found late in the process you may be required to redesign, redevelop, and retest your device throwing your project off the rails. Since having these mitigations and good practices are core to the FDA & CE approval process, you need a diligent medical device risk management process.

Using Experience and Knowledge to Create A Balanced Medical Device Risk Management Process 

Although it is important to have a diligent risk management process, if you spend too much time designing your process it can negatively affect your budget and timeline. It can be difficult to find the right balance. This is where Sterling’s expertise and experience since 1998 with over 1,400 projects can serve as an asset. Sterling has the proper certifications and can ensure that your device meets the proper requirements, so the FDA & CE approval process goes smoothly.

Maximizing Efficiency Through Experience

Our engineering methodologies are optimized to keep expenses low and design times down. We know how to minimize the total duration of the project and maximize your return on investment. This is possible due to our reverse engineering service which allows our clients to quickly create prototypes and utilize prior work to generate all the necessary documentation required for regulatory approval – all without compromising quality. We also employ agile project management by breaking down the project into incremental steps, and then thoroughly reviewing each step. This allows us to efficiently make changes and receive company feedback.

ISO 14971

ISO 14971 is the application of risk management to medical device. It outlines the process you are going to follow for risk analysis. It entails going through risk analysis, a risk evaluation, risk mitigations, and a residual risk analysis and management. This standard helps guide the process for medical device manufacturers to ensure that the product is safe. Sterling’s experts can provide companies with support and documents needed for the ISO 14971 application.

Hazard Analysis

As part of our human factors engineering process, we conduct a hazard analysis to identify potential hazards or hazardous issues from the environment and usability of the device. We also analyze residual risk of the device. Our goal is to ensure the device works properly and safely within its environment.

Software FMEA For Medical Devices

FMEA, which stands for Failure Modes and Effects Analysis, is a process which helps to identify issues before they happen. The first step in this process is to imagine possible risks with the software. The second phase involves deciding how detrimental the risks are to the software as a whole. Based on these steps, the third step is to develop safeguards or mitigations for those risks.

If your team needs support with creating a balanced risk management process, contact our team today.

Resources

design-medical-device-sharp

September 11, 2020

Keys to Success in the Digital Health/Mobile Medical Device Market: Experienced Partners

Digital health, including mobile medical devices and applications, is offering patients, providers, health systems, and insurance carriers’ real-world opportunities to improve medical outcomes and enhance the efficiency of healthcare around the world....
Read More >
View More Blogs

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
Breathing-Pacemaker

September 8, 2020

Breathing Pacemaker

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
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