What is Risk Management

Risk assessment in medical device manufacturing is an ongoing responsibility and must be managed and perceived as a top priority in the organization. Risk management is a framework used to identify, evaluate, and mitigate risk or potential failures throughout a medical device’s development life cycle. It is an integral part of the process of medical device development and manufacturing, utilized to ensure a medical devices’ effectiveness, reliability, and safety for patients and operators alike.

Risk Management Standards for the Medical Device Industry

Risk management standards for the medical device industry, are defined by the ISO 14971 quality standard, as well as local authorities regulations such as the US FDA, the EU EMA and others. It specifies a process that medical device manufacturers use to identify the hazards associated with medical devices, estimate and evaluate the associated risks, how to control these risks, and how to monitor the effectiveness of this risk mitigation process. Following are 5 tips for assessing risk in medical devices, based on the ISO 14971 quality standard for application of risk management to medical devices.

1. Establish a Risk Management Framework

Your first step in effective risk assessment is establishing a framework which apart from being compliant, is also understandable, accessible, and enforced throughout the organization. To achieve this you need to:

• Outline and define your risk management process
• Define position roles and responsibilities
• Establish documentation to be maintained throughout the risk assessment process
• Provide a practical, safe, and easy to use way of maintaining risk assessment documentation, to all responsible and involved personnel

Contact us today to find out how you can benefit from Quasar’s unique capabilities.

2. Define Your Risk Assessment Process

Defining your risk assessment process, requires defining its two main principles: risk analysis and risk evaluation. These are the bedrock of an effective risk management process, as all next steps will be based upon these initial stages.

Risk Analysis

This stage begins by defining the failure mode, or put simply, describing what can go wrong. Next step is the Failure Mode Effect Analysis (FMEA), in order to identify and prioritize risk factors that may cause said failure mode.

Risk Evaluation

Depending on the severity and frequency of occurrence, the risk of every failure mode identified is calculated and evaluated. This evaluation results in defining whether an identified risk is of minor, average, or major critical importance.

3. Risk Control & Mitigation

In risk control, the goal is to mitigate or reduce the risk to an acceptable level. This can be done through various ways:

• Product redesign in order to alleviate the risk factor
• Include protective measures to mitigate a particular risk and decrease chances of occurrence
• Add warning labels or enclose instructions regarding the risk, in order to inform users

4. Risk Management Report

In a risk management report, a review of all of the risk assessment steps is presented, and all protective and risk mitigating measures are summarized. Moreover, this report needs to be signed off by every responsible person, ensuring that there is company-wide consensus on said risk management.

5. Utilizing Post-Production Feedback

Once a medical device’s product development life cycle has ended, it enters the mass production and market phases. During these phases, a lot of real-life feedback is available after actual usage and application of your product. This is the best feedback resource for your medical device that money can buy. Feedback may come internally from the medical device manufacturing facility, as a result of production department internal audits and deviations corrective / preventive actions (CAPA’s).

Even better, valuable feedback can come from external resources such as  customer complaints. This information feeds into the risk management process, where it can be evaluated. Through evaluation, you may reach conclusions such as required product changes, upgrades, or revisions. Conclusions of this can greatly help manage any potential risks that might have been raised during this post-production feedback stage.

Working With Quasar

Needless to say, knowledge gained from the risk assessment process does not only amount to addressing the quality issues of a specific medical device. It is an intangible asset for medical device development companies, which will serve as a basis for the future development of incrementally better, safer, and more effective medical devices. Quasar has amassed a lot of such know how throughout its 30 years of experience developing and mass manufacturing medical devices. By choosing a reliable and knowledgeable partner like Quasar, you can be sure of successful development of your medical device.

Mass Manufacturing

The goal of this stage is to mass produce the medical device product developed, within budget and according to specifications. An effective turn-key medical device development – manufacturer, has addressed mass manufacturing feasibility and regulatory compliance right from the start. In this stage all the hard work and experience placed in the previous stages pays off, and efficient medical device manufacturing is as easy as placing the order for the mass production of the first batch of medical devices.

Gain A Competitive Edge with Quasar

Quasar is ISO 13485 manufacturing certified, and consistently demonstrates its stellar quality of services with world class regulatory bodies such as the US FDA. Consecutive results of zero observations of the FDA Form 483 stand as a testament to Quasar’s impeccably high standard. Quasar has over 30 years of experience in the development and manufacturing of medical devices.