Strategic Solution Architecture • Muhrat Al Marasim
Technical File Authoring & Gap Remediation.
إعداد الملفات الفنية ومعالجة الفجوات التنظيمية
Rigorous Technical Documentation Aligned with SFDA MDS-REQ 1 and IMDRF Standards
Executive Framework
Strategic overview and institutional delivery.
A regulatory submission is only as resilient as its underlying technical file. Muhrat Al Marasim authors, reviews, and upgrades technical documentation to withstand scientific scrutiny from SFDA review committees.
Strategic Solution Pillars
ISO 14971 Risk Management Files
Authoring comprehensive risk management plans, FMEA matrices, and risk-benefit evaluation summaries.
Essential Principles Conformity
Detailed evidence matrices demonstrating compliance with safety, performance, and environmental standards.
Biocompatibility & Sterilization Validation
Review of ISO 10993 biological evaluations, ethylene oxide residuals, gamma irradiation, and shelf-life data.
Bilingual Artwork & UDI Compliance
Artwork adaptation to mandatory Arabic labeling regulations and Global Unique Device Identification (GS1/UDI).
Measurable Corporate Outcomes
Preempts the majority of regulatory deficiency letters
Full compliance with SFDA UDI-DI database indexing
Clear, defensible risk-benefit architecture
Operational Execution Stepper
Interactive StagesDocument Inventory
Comprehensive review of all engineering, bench test, and risk files.
Solution Proposal Blueprint
Configure Engagement Terms
Tailor the operational scope for Technical File Authoring & Gap Remediation: