Tom Wren

Senior Software Test Engineer at Advantu - San Diego, CA, US

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Sarah Guan

Software Quality Engineer

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Cindy Casselman

General Counsel & Chief Executive Officer

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Tim Reynal

Senior Technical Program & General Manager

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Advantu
Tom Wren's Company Details
Advantu logo, Advantu contact details

Advantu

San Diego, CA, US • 20 - 49 Employees
Technology Consulting/Tech Services

Advantu is the leading nationwide Software Quality Assurance/Testing, Software Engineering, SDLC Process Improvement & FDA Regulatory Guidance & Support Firm. We help R&D Teams increase productivity, shrink time-to-market and improve customer satisfaction with their products.Medical Device Manufacturers utilize Advantu's 30 years of Biotech experience to improve Patient Safety for their customers, while benefiting from our Regulatory experience to ensure successful FDA submittals (for the new products in their pipeline), and ensuring their Quality Management System is accurate and complete.Additionally, Pharmaceutical companies have benefited from our expertise via Gap Analysis of their entire QMS, in order to improve R&D/Manufacturing/Supplier Quality and CAPA issue reduction. With their Manufacturing Processes properly aligned with Good Manufacturing Practices (GMP), our clients have reduced line losses and delays, while dramatically decreasing Time to Market for their products.Advantu's proven Risk ID process ensures our clients can prevent product recalls and measurably improve product quality and reliability across their portfolio. This program provides the (value-added) benefit of a high degree of confidence at product release.Headquartered in San Diego, Advantu is privately held by its executive team and is well positioned to support your Medical Device & Pharmaceutical Project across the continent.For content, updates, newsletters and more: http://advantu.com/category/news-blog/

Software Development Process Improvement QA Training Courses Quality Assurance & Testing Services Custom Software Solutions Offshore Program Setup & Execution Performance Measurement & Testing High Risk Quality Assurance & Testing MedTech Industry Challenges Medical Device Recall Prevention SDLC Process Improvement FDA Submittal Optimization Support Performance Measurement & Testing High Risk Quality Assurance & Testing Mission Critical System IV&V Successful FDA Audits Pharmaceutical QMS/GMP Process Improvement Supplier Quality Process Improvement Good Manufacturing Practice Enhancement Gap Analysis of QMS/GMP/SDLC Quality Management Systems QMS Process Improvement Gap Analysis Medical Device Validation Support Quality Engineering Support Regulatory Support Software Test Support FDA Audit Support Software Quality Assurance and Testing Intended Use Validation Medical Device Testing Support Cost Reduction Reduced Cycle Time Defect Density Staff Augmentation Code Complexity Software Engineering Software Development
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