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QS COMPLIANCE!

Quality Systems Compliance, LLC will help you achieve and maintain quality compliance, while meeting deadlines and containing costs. If you plan and implement your quality system correctly, it doesn't have to be expensive to be in a state of compliance. In fact, implementing your quality system correctly the first time can reduce risk and liability. With the assistance of Quality Systems Compliance, LLC, you'll implement a QUALITY SYSTEM plan that will make you compliant as well as profitable!

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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.

CLIENTS

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

Tool and Die Company, MI
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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Quality Systems Compliance provides CUSTOMIZED COURSES delivered to meet your training requirements available in the following topics:

Medical Device Single Audit Program (MDSAP)
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Design of Experiments (DOE)
Introduction to Quality Systems
Sampling Plans (Variable and Attribute)
Introduction to Metrology
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Mechanical Blueprint Reading
Welding Blueprint Reading
FDA Inspection Readiness
Good Documentation Practices (GDP)
Good Manufacturing Practices (GMP)
ASQ Certification Preparation
Corrective and Preventive Actions (CAPA)
Quality System Requirements (QSR Overview)
Introduction to Measurement System Analysis (MSA)
Animal Tissue

Quality Systems Compliance specializes in the following areas:

Internal Audits
Supplier Audits
Gap Assessments
FDA 483 and Warning Letter responses
FDA 483 and Warning Letter remediation
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External regulatory and certification audit support
Document and Procedure Writing & Review
Process Optimization
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Regulatory Affairs support
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Design of Experiments (DOE)
Measurement System Analysis (MSA)
Test Method Validations (TMV)
Corrective and Preventive Actions (CAPA)
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Process Monitoring
Quality Metrics
Procedures and Work Instructions
Sampling Plans (Variable and Attribute)
Training
Medical Device Single Audit Program (MDSAP) Audits
Animal Tissue

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QS COMPLIANCE!