Welcome to ADVANTU

Advantu is a nationwide provider of FDA (Regulatory/Quality) Guidance & Support, Software Quality Engineering & Testing, and QMS/SDLC Process Improvement Services for Medical Device & BioPharmaceutical, Manufacturing & Supplier companies.

“Lina did a great job for us, leading the testing effort. Kris was great as well – very flexible and responsive to any issues. They’re a great team to work with!”

Don Canal
Senior Management – Clarify Medical

We offer a full suite of consulting and professional services that range from gap analysis to software development best practices implementation; from short-term testing to software quality assurance support across all projects and programs. Quality leaders appreciate our quality engineering and validation support as well.

If you are a Regulatory Head, Quality Manager, VP of Engineering, Director of R&D or Software Validation – looking for additional support (to ensure your projects release on time without surprises) then Advantu is here for you.

Additionally, whether you’re the Head of Manufacturing or Director of Supplier Quality, your company can benefit from our Gap Analysis, to ensure your processes are complete, easy to follow and everyone is on the same page. Harmonization across R&D, Manufacturing, Supplier Quality & Vendor Management is critical for business success and increased market share.

“Every day we are challenged with finding ways to improve quality of software development while decreasing time-to-market. Specific areas we focused on were automated tools for development and test, increased transparency and traceability, automated regression analysis and repeatable predictable outcomes.’

‘Advantu’s Quality Process Consultant Charlie Gragg and his team assessed our current development and test situation and presented the best path forward for addressing our specific needs. If you have a similar need, Charlie is the right resource to meet your requirements.’

‘I highly recommend him and his team.’”

Gregory Gulden

Vice President, Device Engineering, Hospital Products

Baxter Healthcare

Our services are supported by in-depth evaluation and remediation experience, regulatory expertise and market-leading system performance measurement and tuning capabilities.

We are the only full-service company that offers the knowledge, experience and capabilities to support new or ongoing embedded, enterprise, cloud and mobile application projects across the technology spectrum – while also assessing and improving the R&D, Mfg & Supplier Quality processes across your entire organization, in order to ensure your products reach the market place early and with best in class quality.

Your customers deserve nothing less than your very best.

Pick onecost, quality or time, and we will show you how Advantu can save you money, improve your product quality, and reduce your time to market: 858.275.2106

A Quote from the FDA’s Case for Quality

Medical device manufacturers can reduce costs and increase their profits by focusing on quality measures during medical device design and production. This quality improvement approach pays dividends in customer satisfaction and provides significant competitive advantages.

In simple terms, our review of device manufacturers that consistently produce high quality devices identified that an investment in quality has long-term payoffs. Quality of medical devices is in everyone’s best interest.”

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