Risk Management Consulting

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The medical device industry is constantly evolving, and with it, the need for effective risk management strategies. At Innovenn, we understand the importance of identifying and mitigating potential risks associated with a medical device, combination drug/device or software as a medical device (SaMD) product. Our team of experts have years of experience in providing risk management consulting services for clients in these industries. We work closely with our clients to develop and implement strategies that reduce the likelihood of product failure and support compliance with regulatory standards.

Risk Management in Product Development


Innovenn can provide guidance and support throughout the complete risk management process in conformance with ISO 14971, from developing a risk management plan to conducting risk management activities. These include:

1

Risk Management Plan

A risk management plan delineates the risk management activities for identifying, assessing, and mitigating risks for the medical device. It also describes the roles and responsibilities of the risk management team.

2

Risk Analysis

A systematic process used to identify hazards associated with device and calculating risk. This includes identifying the potential sources of harm, evaluating the likelihood of harm occurring, and determining the severity of harm if it were to occur.

3

Risk Evaluation

A process used to determine if the identified risks for the device are acceptable.

4

Risk Control

A process for mitigating identified risks by implementing control measures. After the risk control measures are implemented, a residual risk evaluation is conducted to assess if the identified risks are reduced to an acceptable level. If a risk cannot be reduced to an acceptable level, a benefit-risk analysis is conducted to determine if the benefit of the device outweighs the residual risk.

5

Overall Residual Risk

An overall residual risk evaluation is conducted at the end of the project taking into consideration all residual risks in relation to the benefits of the device. If the overall residual risk is judged unacceptable, implementing additional risk controls may be necessary or a risk-benefit analysis may have to be conducted.

6

Risk Management Report

Upon completion of the risk management activities, a comprehensive review is conducted to verify adherence to the risk management plan. Results of the risk management activities and the comprehensive review are summarized in the risk management report.

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FAQs

Risk management is the process of identifying, assessing, and mitigating potential risks associated with the development and use of medical products. This includes identifying potential hazards, evaluating the likelihood and severity of harm, and implementing strategies to minimize or eliminate those risks.

Innovenn’s team of experts use a structured risk-based lifecycle process following ISO 14971 to assist clients in identifying and mitigating potential risks throughout the product development process. This includes risk management in the product definition phase, hazard analysis, providing risk identification and mitigation prior to prototype design, and residual risk analysis. Innovenn is also able to provide substantive support for your regulatory filing by writing various risk managing documents such as the risk management plan, risk analysis documents (Hazard Analysis, Failure Modes and Effects Analysis (FMEA)), and risk management report.

Some examples of risks that need to be evaluated and mitigated in medical device development include use-related risks, risks associated with loss of function of device, cybersecurity risks (if applicable), and process risks.

Yes, Innovenn’s team has extensive experience in working with drug, medical device and SaMD manufacturers to support compliance with US and international regulatory standards. They also offer technical writing and agency/vendor meeting support to assist in the submission process.

Why Choose Innovenn for your Risk Management Services?

Innovenn’s risk management services can help medical device manufacturers evaluate product are safety, efficacy and compliance with regulatory standards. By identifying and mitigating potential risks early in the development process, manufacturers can avoid costly delays or post-market recalls. Additionally, by providing risk identification and mitigation prior to prototype design, Innovenn’s team can help reduce the costs associated with developing a device that may not be successful in the market.

To learn more about Innovenn’s risk management consulting services, contact us to discuss your specific needs.

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6410  Enterprise Lane
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Madison, WI 53719

608-203-9748

info@innovenn.com

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