Consulting

• Interpretation of FDA Regulations as they apply to Software
• Assessment of Software Lifecycle Processes
• SOP Development
• Software Safety Risk Management

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  Or Call 269.352.9000

Software Validation

Have your software validated off site.

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  Or Call 269.352.9000

Resources

Training

• Developing FDA Compliant Medical Device Software
• Software Quality Assurance
• Software Safety Risk Management
• IEC 62304 Overview

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  Or Call 269.352.9000

Audits and Assessments

Understand how your software processes and products align with regulations and standards with an on-site assessment.

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  Or Call 269.352.9000