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MEDICAL DEVICES

IMPLEMENTING HIGH-QUALITY STANDARDS

INTRODUCTION

Tailored to meet the unique challenges of the medical device manufacturing industry

Our powerful Manufacturing Operations Management (MOM) solution provides the flexibility and scalability you deserve to optimize your most important resources and profitably grow your company.

 

Benefits of Solumina for Medical Devices

Compliance

Solumina is an integrated Manufacturing Operations Management (MOM) system that helps manufacturer’s meet an array of regulatory requirements and standards including FDA’s 21 CFR Part 11 and CFR 820, ISO 13485, and ISO 9001. Since medical device product information is extremely stringent, due to governmental and industry regulations, Solumina consolidates all compliance information into one centralized system – automatically updating the eDHR from design through production. This eliminates any chance of manual errors, making audits easier and less time consuming.

Electronic Device History Records (eDHR)

21 CFR Part 820 requires medical device companies to maintain a DHR on all their products. Some of the eDHR information Solumina tracks includes parts and Bills of Material information, quantity, dates manufactured, labeling information, Supplier and PO information, lot and serial numbers, inspections and test results, non-conformances, electronic signatures, document revisions and tools used during assembly. Solumina extends beyond eDHR with end-to-end quality procedures including: supplier quality, CAPA, nonconformance management, and maintenance & repairs.

Solumina Quality Management

Quality management is one of the most critical aspects of manufacturing. Solumina dramatically increases manufacturing efficiency by eliminating costly, error-prone paper-based quality processes and streamlining the tracking, documenting and resolution of manufacturing quality incidents – exceptions, defects, deviations, failures and non-conformances – across the entire factory floor. Every step of the manufacturing process is monitored, tested, and recorded for FDA, ISO and GMP compliance.

Full Bi-directional Traceability

Solumina provides strong control and visibility over lot and serial tracked parts from the cradle to the grave, because the need for bi-directional traceability for medical device manufacturers is critical. Solumina’s product genealogy includes intuitive support for tracking materials, components, and subassemblies used for each unit, subassembly, and completed product. A product’s genealogy can be quickly queried to determine which products contain or used a component or material that was out of compliance.

Fast Deployment

Increase the speed and accuracy of doing business in today’s competitive environment by streamlining your production and quality operations. With Solumina’s rapid-deployment, iBASEt brings together the software and services you need to go-live with a rich set of MOM functionality in under 6 months. Each implementation is tailored specifically for the medical device industry, providing faster implementations with predictable outcomes and lower total cost of ownership.

Dynamic Work Instructions

Solumina’s dynamic work instruction capabilities allow users to create simple work instructions and illustrations to more advanced instructions with 3D-model animations, videos, slideshows, and built-in data collections and signature prompts. Work instructions can be configured to display only the options required and provide speed buttons for the most commonly used commands. These are just a few of Solumina’s advanced features that reduce errors and create a lean environment.

Proven Integration

Solumina Manufacturing Operations Management (MOM) system easily integrates with all popular CAD, Product Lifecycle Management (PLM) systems, and Enterprise Resource Planning (ERP) in addition to 3rd party and legacy systems our manufacturing customers are using today.

Out-Of-The-Box Solution

Many of our discrete manufacturing customers with diverse production requirements have successfully implemented Solumina as an out-of-the-box solution. Longtime customers have been able to upgrade and replace old custom code with newer out-of-the-box functionality.

Inspection & Audit

Solumina dynamically generates inspection and audit requirements for each PO line item. The requirements are produced based on the most recent history for a specific part family and for a specific supplier

Solumina Alerts

Users are notified when there are invalid entries, non-qualified personnel, out of compliance tools, and outstanding data collections and measurements outside of the specific control limits.

CAPA

Solumina enables investigation of the root cause analysis, assigns follow up actions per SOPs and guidelines while effectively tracking and routing cases from their initiation to final closure.

Six Sigma

Solumina is designed around Six Sigma strategies and techniques to enable manufacturers to meet cost objectives and schedules more efficiently, consistently, and at lower cost.

Earlens Selects iBASEt to Support 3D Printing of Revolutionary Hearing Aid

PRESS RELEASE

“We are excited to work with iBASEt to put in place an innovative technology manufacturing infrastructure,” said Mark Bishop, VP of Operations of Earlens. “We believe it is a smart move for us to implement an MES/QMS solution now, in the early stages of our business, so that we can rapidly scale production to meet growing demand for our product and keep pace with design changes and improvements.”

READ MORE

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May 9, 2017
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SQM for AS9100 Compliance

May 1, 2017
Supplier Quality Management (SQM) is a crucial step toward AS9100 Rev D compliance. Learn more in about SQM in aerospace.
eBOOK

5 Strategies for Improving Medical Device Quality

eBOOK

7 Strategies for Improving A Medical Device Manufacturer’s Supplier Quality Management Initiative

eBOOK

Five Strategies for Improving MES in Medical Device Manufacturing

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