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21 CFR 820 Proposed QMSR with TOC

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21 CFR 820 QSR and Preamble with TOC

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21 CFR 820 Quality System Regulation with TOC

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21 CFR 821 Medical Device Tracking Requirements with TOC

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21 CFR 830 Unique Device Identification with TOC

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21 CFR 1271 cGMPs for HCTPs with TOC

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21 CFR 4 Regulation of Combination Products with TOC

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21 CFR 7 Enforcement Policy with TOC

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medical device regulation quick reference checklist
EU Medical Device Regulation (EU MDR) 2017-745 Quick Reference

Medical Device Regulation (MDR) 2017-745 Quick Reference Regulation (EU) 2017/745 Medical Device (EU MDR) of [...]

in-vitro diagnostic regulation quick reference
EU In-Vitro Diagnostic Regulation (EU IVDR) 2017-746 Quick Reference

In-Vitro Diagnostic Regulation (IVDR) 2017-746 Quick Reference Regulation (EU) 2017/746 In Vitro Diagnostic Medical Devices [...]

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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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