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Your Quality and Regulatory professional

Transform your approach to quality and regulatory management with our expert consulting designed for the medical device and healthcare sectors.

Total Quality Solutions LLC

CT Scan Machine

Our Commitment to Quality

Total Quality Solutions is committed to advancing quality and compliance in the healthcare sector. With over 15 years of experience, and ASQ and Exemplar Global certifications as Lead Medical Device Auditors, we work diligently with clients to navigate the complexities of FDA and ISO with precision and expertise.

Our over 15 years of experience in the field, together with a background in six sigma and LEAN principles ensures a focus on operational efficiency, ensuring your Quality Management System not only meets industry standards but also supports your business objectives. Collaborate with us to foster a culture of continuous quality improvement.

Services

Quality Consulting

We provide comprehensive consulting solutions tailored to each individual client, ensuring compliance and optimizing operational performance.

Consulting

Our consulting services focus on building robust Quality Management Systems for medical device manufacturers and service providers.

Auditing

We offer thorough third party and internal audits to ensure compliance with FDA and ISO standards. Let us handle your supplier audits or be an impartial internal auditor.

Support

We offer fractional quality management and ongoing support and guidance to maintain your compliance status and optimize performance.

Get in Touch

Green Bay, Wisconsin, USA

920-660-6285

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