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Quality/Regulatory

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Quality/Regulatory 2017-04-17T08:43:03+00:00

Our quality assurance support services include risk management, failure analysis, verification and validation, statistical techniques, process capability studies, data collection and analysis. We also provide worldwide regulatory support and assistance.

Quality Assurance

• Internal and supplier audits
• Quality planning and systems
• Continuous improvement tools
• Failure and Root cause analysis

Reliability, Verification and Validation

• Standards and Regulatory
• Process Validation
• Design Verification
• Software Validation
• Reliability testing and evaluation (MTBF)
• Risk analysis and management

Regulatory

• Registered with FDA as a GMP manufacturer
• Experience with regulatory class I, II, and III devices
• Compliant with current FDA Quality System Regulations
• Compliant with current EU directives for CE Mark