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Tag Archives: In Vitro Diagnostic Products

21 CFR 809 In Vitro Diagnostic Products for Human Use with TOC

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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.
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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)

Member, American Association of Tissue Banks (AATB)

Contact Us

3118 Chanson Valley Rd
Lambertville, MI 48144

mark.durivage@qscompliance.com

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