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Medical Device Company, IN

I believe we learned more from his audit than anyone that has audited us since [...]

Tool and Die Company, MI

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

How Much Do You Know About MDSAP?

  A full Medical Device Single Audit Program (MDSAP) Audit is comprised of seven chapters, [...]

Ask a Question About Quality Systems or Compliance

  There is quite a bit of information on this site, as well as published [...]

Risk-Based Approaches To Establishing Sample Sizes For Process Validation
Risk-Based Approaches To Establishing Sample Sizes For Process Validation

Following is an article about the Risk-Based Approaches To Establishing Sample Sizes For Process Validation [...]

How To Establish Sample Sizes For Process Validation Using The Success-Run Theorem

How To Establish Sample Sizes For Process Validation Using The Success-Run Theorem [...]

New Supplier Quality Professional Certification Set

New Supplier Quality Professional Certification Set [...]

How To Use Reliability-Based Life Testing Sampling For Process Validation

How To Use Reliability-Based Life Testing Sampling For Process Validatio… [...]

How To Establish Sample Sizes For Process Validation When Destructive Or Expensive Testing is Required

How To Establish Sample Sizes For Process Validation When Destructive Or Expensive Testing is Required [...]

How To Establish The Number Of Runs Required For Process Validation

How To Establish The Number Of Runs Required For Process Validation [...]

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Training

Quality Systems Compliance provides
CUSTOMIZED COURSES to meet your training requirements, available in the following topics:

  • Medical Device Single Audit Program (MDSAP)
  • Statistical Process Control
  • Design of Experiments (DOE)
  • Introduction to Quality Systems
  • Sampling Plans (Variable and Attribute)
  • Introduction to Metrology
  • Introduction to Process Validation
  • Documentation & Audit Preparation
  • 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
Specializations

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
  • Risk-based auditing systems (internal & supplier)
  • External regulatory and certification audit support
  • Document and Procedure Writing & Review
  • Process Optimization
  • Management Review
  • Regulatory Affairs support
  • Mock FDA Inspections
  • Design of Experiments (DOE)
  • Measurement System Analysis (MSA)
  • Test Method Validations (TMV)
  • Corrective and Preventive Actions (CAPA)
  • Process Validations
  • Process Monitoring
  • Quality Metrics
  • Procedures and Work Instructions
  • Sampling Plans (Variable and Attribute)
  • Training
  • Medical Device Single Audit Program (MDSAP) Audits
  • Animal Tissue
Awards & Memberships

Recognized as a Top Ten Medical Device Consulting Company in 2019 by MedTech Outlook.
Read Full Article ►

Top 10 Medical Device Consulting Companies 2019
Member, Society of Reliability Engineers (SRE)
Member, Regulatory Affairs Professionals Society (RAPS)
Member, Association for the Advancement of Medical Instrumentation (AAMI)
Contact Us
3118 Chanson Valley Rd
Lambertville, MI 48144
mark.durivage@qscompliance.com

(419) 265-2862

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