GJA Consulting LLC — Quality, Regulatory, Compliance, Performance

GJA QUALITY STORE

SOPs, Quality Manuals, Templates, Training Materials and QMS Implementation Tools for medical device and life sciences companies.

Quality & Regulatory

Professional resources

Customizable

Editable document formats

Expert Support

Practical guidance

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Document Control SOPGJA CONSULTING LLC
FDA QMSR · ISO 13485DOCX

Document Control SOP

A procedure outline for document approval, revision and distribution.

$49.00USD
Medical Device Quality ManualGJA CONSULTING LLC
FDA QMSR · ISO 13485DOCX

Medical Device Quality Manual

A customizable starting point for a medical device quality manual.

$149.00USD
CAPA Form SetGJA CONSULTING LLC
ISO 13485DOCX + XLSX

CAPA Form Set

Templates for investigation, action planning and effectiveness checks.

$29.00USD
ISO 13485 Awareness TrainingGJA CONSULTING LLC
ISO 13485PPTX + PDF

ISO 13485 Awareness Training

Presentation materials covering quality management fundamentals.

$79.00USD
Medical Device QMS Starter PackageGJA CONSULTING LLC
FDA QMSR · ISO 13485DOCX + XLSX

Medical Device QMS Starter Package

A sample bundle of a quality manual, core procedures and forms.

$399.00USD
ISO 13485 Audit ChecklistGJA CONSULTING LLC
FDA QMSR · ISO 13485XLSX

ISO 13485 Audit Checklist

A worksheet for organizing internal audit questions and findings.

$39.00USD

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