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About Insight Technology

Consulting Services

Contract Manufacturing

Insights

Statistics: Our insights will let you see your history under a new light. What you learn will reduce dispersion, and enhance your ability to meet project requirements within budget and schedule.

NPD: We provide assurance of design and process validation, so safe and effective medical devices, and combination products are designed, manufactured, and delivered on time, to spec, and cost effectively.

QA/RA: We focus resources on key factors that impact product safety, and efficacy, facilitate compliance, and communication with FDA, to positively enhance shareholders value.

Remediation: We facilitate Post-Market Surveillance to reduce complaints, and Remediation work, and speed up compliance.

Sustenance: We establish a fast feedback loop between Sales, Quality, and R/D to address the field issues before they become regulatory concerns.

Key metrics:

• Lead time to new product development and changes to existing products
• Cost of compliance
• Response time to reaching closure with FDA on 510k, PMA, 483, WL or field actions
• Post-Market product safety, and performance, MDR's, Complaints, and CAPA's
• Level of focus in scientific, risk-based approach to QA/RA and NPD
• Level of commitment to Retrospective Validation.

Reducing Variations. Simplifying Design Control & Product Realization.

Copyright 2014 Insight Technology. 28581 Springfield Drive, Laguna Niguel, CA 92677 (949) 363-6047.