QMS Establishment & Management

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An effective Quality Management System creates the foundation for sustainable growth. GSAP designs and implements scalable QMS frameworks tailored to each organization's products, technologies, and regulatory environment, helping teams build quality into every stage of development and commercialization.

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Our services include:

  • Drafting and Review of Quality Manual and Policy.
  • Drafting Quality Objectives.
  • Audits (Mock FDA, ISO 13485, ISO 27001, ISO 14155, MDSAP, MDR, etc).
  • Assessing your list of applicable standards.
  • SOPs development
  • SOPs review or adaptation
  • Gap Analysis and support in executing work plan (ISO 13485:2016, QMSR, MDR, etc).
  • MDR/IVDR Gap Analysis and performing system upgrade.
  • Process management and assistance such as CAPA, Document Control, ECO, Suppliers etc.
  • Assessment before transfer to production.
  • Reviewing complaint system.
  • Aid in Preparation of Management Review – presenting meaningful statistics
  • DHF – Establishment, Remediation in cooperation with the R&D team
  • Transfer to production quality and validation processes
  • Vendor remediation

 

Audits

  • ISO 13485 Internal Audits
  • FDA QMSR (21 CFR Part 820) Audits
  • Mock FDA Inspections & Inspection Readiness
  • Notified Body & MDR Readiness Assessments
  • MDSAP Audits
  • Supplier & Subcontractor Audits
  • Clinical Study Audits
  • Internal Quality System Audits
  • ISO 27001, HIPAA & GDPR Audits

 

Compliance

  • FDA Inspection Readiness
  • Mock Audits
  • Compliance Work Plans
  • Inspection Preparation & Personnel Training
  • Remediation Implementation Support

 

Violations & Remediation

  • FDA Form 483 Response
  • FDA Warning Letter Remediation
  • Notified Body Non-Conformity Response
  • Root Cause Analysis
  • CAPA Planning & Implementation
  • Quality System Remediation
  • Regulatory Compliance Recovery