Strategic Solution Architecture • Muhrat Al Marasim
QMS, ISO 13485 & GDP Certification.
أنظمة إدارة الجودة وشهادات الآيزو وممارسات التوزيع الجيد
Robust Quality Frameworks Tailored for Middle East Audits and Global Compliance
Executive Framework
Strategic overview and institutional delivery.
Quality Management Systems are the bedrock of regulatory approvals. We build, audit, and remediate QMS architectures complying with ISO 13485:2016, ISO 9001, SFDA Good Distribution Practice (GDP), and Good Storage Practice (GSP).
Strategic Solution Pillars
ISO 13485:2016 QMS Implementation
Complete documentation authoring, quality manuals, standard operating procedures (SOPs), and CAPA systems.
Warehouse & GDP Licensing (MDEL)
Preparation of medical storage facilities, temperature mapping, pest control, and SFDA warehouse licensing.
Pre-Audit Mock Inspections
Simulated notified body and SFDA auditor visits to identify non-conformances prior to official certification.
Internal Auditor Training
Accredited training for internal quality champions to ensure enduring system integrity.
Measurable Corporate Outcomes
100% first-attempt certification record with accredited registrars
Rapid turnaround for SFDA Medical Device Establishment License (MDEL)
Institutional resilience against post-market surveillance audits
Operational Execution Stepper
Interactive StagesBaseline Gap Analysis
Detailed evaluation of existing operations against ISO 13485 clauses.
Solution Proposal Blueprint
Configure Engagement Terms
Tailor the operational scope for QMS, ISO 13485 & GDP Certification: