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Quality Systems Compliance LLC was founded in 2012 by Mark Allen Durivage. He saw an opportunity to serve the needs of businesses working in the FDA Regulated Industries including Medical Devices (21 CFR 820), Pharmaceuticals (21 CFR 211), Tissue (21 CFR 1271). He also provides services to non-FDA Regulated Industries which include ISO 9001 Quality management systems – Requirements, ISO 14001 Environmental management systems, IATF 16949 Quality management systems - Particular requirements for automotive production and relevant service part organizations, ISO 45001 Occupational health and safety management systems - Requirements with guidance for use, and ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories. The company specializes in Quality Compliance, Quality Assurance, Quality Systems, and Quality Control.

About Mark Durivage


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    Mark handled the entire auditing process from start to finish. I didn’t have to worry about anything. I appreciate companies that meet their deadline and deliver more than what I expect. I will use QS Compliance next year as well.

    Toledo-based Medical Business

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    Mark was a speaker at a conference I attended so my company decided to hire him for staff training. He kept everyone’s attention, added humor, and impressed us with his industry knowledge. What I like is that you talk directly to Mark and he gets the job done quick.

    Cincinnati-based Pharmaceutical Company: Sarah D.

  • Tool and Die Company, MI

    You helped us so very much with your drive and expertise.

    Tool and Die Company, MI

  • Medical Device Company, IN

    I believe we learned more from his audit than anyone that has audited us since I started here in 2011. I believe we can make the improvements from his findings and be ready for our certification audit this November. It was a pleasure to work with Mark. He is very professional but also kept things “light” and enjoyable.

    Medical Device Company, IN

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