Medical Device

iBase-t experts guide you with the control, compliance, flexibility, and scalability to optimize your most important resources and profitably grow.


Competing in a Highly Regulated Industry

The medical device industry combines the complexity of highly engineered products with multiple, stringent regulatory requirements, in a market where failures can be catastrophic. Solumina from iBase-t is designed for this kind of challenging environment, helping you maintain quality, meet regulatory compliance and stay competitive at the same time.

Now Complexity Can Be Your Competitive Edge

The Medical Device industry builds many critically complex, intricate and complicated products while being challenged by pressures of cheaper, faster, safer and better innovation. Shifting global supply chains and labor talent challenges make the complexity even greater. Solumina gives you the control and visibility needed to deal with these pressures while accelerating throughput, time to market and profitability.


Integrate Quality Management At All Operations Points

Cost tradeoffs between how much is spent on prevention versus fixing quality failures is a constant in manufacturing environments. Our integrated Enterprise Quality Management System helps you take early action, lowering total cost of quality by reducing defects. Embedded quality control throughout the process leads to more ownership of quality by production personnel, speeding up operational efficiency.


Benefits Of Solumina For Medical Devices

The Solumina platform provides an innovative approach to simplifying how complex manufacturing, quality, and MRO processes are managed and improved to accelerate Industry 4.0 and Smart Manufacturing strategies.

Ensure Compliance

Meet regulatory requirements and standards including FDA’s 21 CFR Part 11 and CFR 820, ISO 13485, and ISO 9001.


Electronic Device History Records are consolidated and automatically update from design through production.

Built-in Quality

Quality management is embedded in Solumina, letting you hard-wire quality procedures into your production process.

Full Traceability

Gain control & visibility over lot and serial tracked parts for all materials, components, and subassemblies from cradle to grave.

Error Reduction

Improve quality with standard work instruction illustrations, 3D-models, videos, slideshows, and built-in data collections.

Auditing & Reporting

Meet reporting requirements easily and generate audits to ensure compliance with internal and external standards.
User Stories
“We believe it’s smart to implement an MES/QMS solution now, so we can rapidly scale production to keep pace with design changes.”
Mark Bishop, VP of Operations, Earlens
Additional Resources

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