Overview
ISO 13485-Based Regulatory & Quality Solutions
MRG Quality Services is dedicated to supporting medical device manufacturers and regulatory stakeholders through structured, audit-ready Quality Management Systems aligned with ISO 13485:2016 and applicable regulatory requirements.
We bridge the gap between regulatory requirements and practical implementation, ensuring organizations achieve compliance, maintain control, and remain inspection-ready throughout the product lifecycle.
Key Focus Areas
- Consulting Services (QMS & Regulatory Compliance)
- Training & Competence Development
- Quality & Compliance Audits
- Medical Device Manufacturers (Primary Focus — ISO 13485)
Capabilities
Core Capabilities
Specialized quality & training regulatory services designed for MENA market access and ongoing compliance.
GMP Audits
Pre-approval and routine GMP audits for pharmaceutical and cosmetics manufacturing sites.
ISO 13485 Support
QMS gap analysis, documentation development, and certification preparation for device manufacturers.
Regulatory Training
Custom workshops on SFDA, MOHAP, and EDA submission requirements and best practices.
Mock Inspections
Simulated authority inspections to identify gaps before official regulatory visits.
SOP Development
Standard operating procedure authoring aligned with GMP, GDP, and ISO requirements.
CAPA & Deviation Management
Corrective and preventive action program design and deviation investigation support.
Our Process
Regulatory Process Timeline
Select your target market to view the authority-specific registration pathway for Saudi Arabia, the UAE, or Egypt.
SFDA GMP Needs Assessment
1 weekEvaluate quality system maturity against SFDA GMP requirements and identify audit, training, or remediation priorities.
Program & Curriculum Design
1–2 weeksDevelop a customized audit scope, SFDA regulatory training curriculum, or QMS implementation plan for your facility.
Audit, Training & Implementation
2–8 weeksConduct on-site GMP audits, deliver SFDA-focused training workshops, or implement quality system improvements.
Findings Report & CAPA Plan
1–2 weeksDeliver audit findings with prioritized corrective actions aligned to SFDA inspection expectations.
Mock Inspection & Follow-Up
OngoingSimulate SFDA inspections, verify CAPA closure, and support ongoing inspection readiness.
Documentation
Required Documents
Select your target market to view the authority-specific documentation required for Saudi Arabia, the UAE, or Egypt.
SFDA GMP Audit Preparation
- Quality manual and site master file
- Batch manufacturing and packaging records
- Deviation and CAPA logs
- Equipment qualification documentation
Training & Competency
- Employee training matrices
- SFDA GMP training curricula and materials
- Competency assessment records
- Annual training plan documentation
Quality System
- Standard operating procedures (SOPs)
- Change control and document control records
- Supplier qualification files
- Management review meeting minutes
Regional Coverage
Quality & Training
Saudi Arabia · Egypt · UAE · MENA Region
Kingdom of Saudi Arabia
- SFDA-aligned GMP audit programs
- Pharmaceutical manufacturing site inspections
- SFDA regulatory affairs training
- Mock SFDA inspection preparation
FAQ
Frequently Asked Questions
Common questions about quality & training regulatory requirements in KSA, UAE, and Egypt.
We offer pre-approval audits, routine surveillance audits, gap assessments, and mock authority inspections for pharmaceutical, cosmetics, and medical device manufacturing and distribution facilities.