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Medical Device Engineering

Risk Management with Minerva Medical Device PLM

Medical device manufacturers operate in an increasingly regulated, safety-critical environment, and frequently have many variants of parts, products, and product lines. Medical Device PLM provides essential engineering support to equip these device makers with efficient solutions to these key business challenges.

Medical Device PLM provides traceability across requirements, designs, and test protocols to address complex regulatory compliance reporting. Risk and hazard management provides coverage of risk with measurable controls and satisfies key regulatory reporting requirements of the European EU MDR/EU IVDR, the American FDA CFR 21 Part 820 and the MDSAP, which will cover Canada, Brazil, Australia, and Japan. Finally, sophisticated reuse capabilities for variant management of parts, products, or product lines reduces duplicate data and rework.

Risk management activities are critical to ensuring the delivery of safe and effective medical devices. All hazards must undergo complete risk analysis to uncover potential safety or usability issues. If a risk is discovered, it needs to be evaluated and, if warranted, actively managed with risk control measures. Both risks and associated control measures must be traceable to design artifacts (e.g. requirements, design specifications, test protocols) so status can be tracked and updated as development proceeds and requirements and designs are updated. Engineering teams often rely on Word documents or Excel spreadsheets to capture these artifacts, but these tools cannot provide the traceability or visibility needed to effectively manage risk.

 

The complexity of the software lifecycle

At the core of product engineering are the systems and software development processes that connect all engineering artifacts. Software is driving innovation in the development of medical devices, which in turn adds a new layer of complexity with respect to quality, interoperability, and performance in both typical and extreme operating conditions. Mitigating the risks of this complexity requires that software components be identified and classified, based on safety analysis, and directly traced to relevant design artifacts. The traceability from a software component to design artifacts must actively manage any changes in requirements or designs that impact software, while the safety classification is used to determine the level of risk management required to be performed.

 

The solution

You are seeking a comprehensive solution - one that is capable of managing risk, one that ensures complete coverage of all requirements, design specifications, and software components, and provides easily navigable links to verification and validation tests to demonstrate both process and product quality. Minerva Medical Device PLM offers a complete single-solution approach where product design, risk management as well as verification and validation activities, and artifacts are all managed in a single platform.

Device manufacturers can easily demonstrate compliance, support cross-discipline collaboration, and provide a foundation for re-use and innovation with the Minerva Medical Device PLM. The solution is built on the foundation of Medical Device PLM’s uniquely powerful process and workflow engine and includes configurable, quick-start process templates built to the specifications of world-leading medical device manufacturers.

The Minerva Medical Device PLM solution supports multiple roles on your extended product development, project management, compliance, and quality management teams, promoting transparency of information and cross-discipline collaboration.

About the author

Thomas Skogen

Thomas is an expert in Supply Chain and Manufacturing Optimization with more than 10 years of experience originating from Medical Device and High-Tech & Electronic Industries. He comes with a background as an Electronics engineer, complimented with a Master in Technology Management. Thomas has held positions in multinational corporations such as Nilfisk, heading the internal optimization program as well as the supply chain organization.

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