Effective risk management systems have been a hot topic for all regulatory authorities to ensure devices are safe and effective, and that the benefits outweigh the risks. Risk management is the systematic application of management policies, procedures, and practices to analyze, evaluate, control, and monitor risk. It requires management to be involved with putting established written procedures in place. These risk management procedures and plans describe how to:
- Conduct risk assessments;
- Review risk management activities;
- Evaluate risk controls and their effectiveness;
- And incorporate production and post-production activities.
Located in Ashland, MA, MEDIcept can help organizations identify, develop, and implement corrective measures to reduce financial losses, health risks, and environmental damages.
Benefitting from Risk Management
Well-designed risk management systems, offer medical device companies many benefits. Some of these include:
- A reduction in financial losses
- The elimination of inappropriate risk-taking
- Assurance that the benefits outweigh the risks
- Increased safety and effectiveness of products
- Harmonization of standards across international markets
It allows small and large organizations alike to protect the organization and its customers from potential risks while ensuring compliance with regulations and industry standards. For an risk management system to be ISO 14971:2019 compliant, it must incorporate activities in the device design and development as well as throughout the life cycle that are proportional to risk.
Risk management must have links to product realization, change controls, outsourcing, software validation, purchasing, validation of production processes, and post-production. Risk management must have links to product realization, change controls, outsourcing, software validation, purchasing, validation of production processes, and post-production. Our experienced MEDIcept consultants in Ashland, Massachusetts can help you develop and implement successful, compliant risk management systems that are tailored to your device’s lifecycle and quality management system
Risk management systems can be complicated because each manufacturer can place a different value on the acceptability of risk in relation to the anticipated benefits. The generally accepted concept of risk contains the probability of occurrence of harm and the severity of harm. These are defined by the stakeholder with a rationale of how they arrived at those conclusions. MEDIcept can help you create these risk evaluation matrices and risk acceptability criteria to ensure your benefits outweigh the risks.
Utilizing Risk Management in Your Organization
MEDIcept can also ensure you are utilizing all the correct inputs in your risk management systems. We can teach you how to create and utilize Design and Process FMEAs by connecting them to your hazard analysis. In your hazard analysis, our experts can also help evaluate the risk estimation for your hazards and connect them to the verification of your controls, any residual risk factors, and your post-market surveillance feedback system. It is also extremely important to consider misuse and usability when it comes to risk management. We provide the tools, resources, and guidance needed to ensure that your organization can maximize its potential and remain competitive.
We have firsthand experience developing, implementing, and maintaining proven risk management systems for a wide range of medical device manufacturers. Whether you are a one-person start-up or a multi-facility global medical device company, we have the expertise to support your needs.
Contact MEDIcept to learn more about how we can help you create risk management systems, that meet all applicable standards and guidelines. Our team of experienced consultants and project managers will work closely with you to develop a customized solution that meets your requirements while also achieving compliance with the relevant regulations.