Quality Management Simplified
Our Services
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QMS Implementation and Management
Our QMS Implementation and Management service involves customizing and setting up Quality Management Systems tailored to FDA requirements, ensuring efficient and compliant operations for your medical device company. We also offer ongoing QMS management and support for specific quality processes — such as CAPA, document control, internal audits, supplier management, and training — to keep your system compliant and continuously improving.
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Internal and Supplier Auditing
Ensure your Quality Management System and supply chain meet ISO 13485, FDA 21 CFR 820, and MDSAP requirements. All-In-One Quality Solutions provides clear, actionable audits—whether you need a focused internal review or a full supplier evaluation. Each audit delivers practical recommendations to strengthen compliance, reduce risk, and prepare confidently for certification or inspection.
About
our company
All-In-One Quality Solutions was built on over five years of hands-on experience in Medical Device Quality Management. We have worked directly with both global corporations and small manufacturers, gaining a deep understanding of how compliance drives success in this highly regulated industry.
That experience includes transforming struggling QMS programs—guiding organizations on the brink of losing ISO certification to passing audits with zero major non-conformances. This practical insight into the challenges of implementation and certification shapes the company’s results-driven approach today.
Through All-In-One Quality Solutions, that same expertise is now dedicated to helping manufacturers strengthen their systems, achieve compliance, and build sustainable quality frameworks that thrive in the competitive U.S. market.
Contact Us
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