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MEDICAL DEVICES

Structured Mapping and Digitalization for Fast and Compliant Device Development

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MEDICAL DEVICES

See what Minerva can do for you
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Minerva’s R3 Quality Investigations

R3 stands for Rapid Response, Effective Resolution, and Permanent Reduction.

Minerva’s R3 approach provides a comprehensive solution to all your process and quality investigation needs, avoiding the recurrence of issues while ensuring optimal outcomes.

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Enhanced product and process understanding

through detailed diagrams and clear visualizations, ensuring optimal device performance.


Cloud-based database platforms

for seamless information management, collaboration, data sharing, resource optimization, and faster investigation resolution.


Robust risk assessment frameworks

to identify, evaluate, and mitigate potential failures for compliant device development and manufacturing.


Advanced visualization

for enhanced communication and understanding of complex procedures.

For job aids and training materials with clear visual representations of reality to improve decision-making, collaboration, and risk reduction.

Process Characterization and Risk Management.

Digital knowledge management systems

for deeper process understanding, effective knowledge retention, and stimulating innovation.


Software risk assessment and mitigation

to strengthen reliability and security, through detailed operations and security mapping to identify and address risks, promote innovation and foster continuous improvement.


Risk-based improvements to manufacturing steps

through thorough mapping and visualization to optimize processes, mitigate potential risks, and ensure regulatory compliance.


Modeling and implementation of Manufacturing Execution Systems (MES)

for fast migration to automation and electronic records.


UML activity diagrams

for detailed characterization of processes and enhanced manufacturing definition.


Digitalized Quality Systems

Implementing digitalized quality systems to ensure compliance, enhance traceability, and optimize the performance of medical devices.


Risk-based design verification and validation

using protocols directly curated from an integrated operations and risk file.


Our Commitment

Transform the medical devices industry through integrated visual and digital knowledge and risk management.