Medical Device Technical Documentation Management System

 

Medical Device Technical Documentation Management System

A comprehensive, professional Excel-based system for preparing and managing the Medical Device Technical File, designed specifically to meet the requirements of the Saudi Food and Drug Authority (SFDA), and compliant with international standards: ISO 13485:2016, ISO 14971, and EU MDR 2017/745.

Overview                                                        

A ready-to-use solution combining 31 interconnected sheets that cover the entire medical device lifecycle — from manufacturer and design data, through risk management, testing, and production, all the way to labeling, certificates, and post-market surveillance. Pre-configured by default for a Three-Ply Medical Face Mask (EN 14683), and easily adaptable to any other medical device.

Built in accordance with the requirements of the Saudi Food and Drug Authority (SFDA) for medical device registration and marketing authorization.

 Who Is It For?

• Medical device manufacturers seeking SFDA-compliant technical documentation
• Quality Assurance & Regulatory Affairs (QA/RA) professionals
• Companies registering their products with the Saudi Food and Drug Authority
• Consultants in medical device regulatory compliance

•  Key Features

Comprehensive Coverage (31 sheets) Document Control

• Manufacturer & Product Data
• Specifications & Bill of Materials
• Design Inputs/Outputs
• Risk Management
• Performance & Biological Testing 
• Clinical Evaluation
• Manufacturing & Calibration
• Labeling & UDI
• Quality System
• CAPA
• Post-Market Surveillance
• Certificates.

• Built-in Automation 

Automatic RPN risk calculator (S×O×D) with residual-risk evaluation

Self-updating validity alerts for certificates and calibration (Valid / Due Soon / Overdue)

Color-coded risk-matrix heat map that updates instantly with values

🔄 Dynamic & Scalable All records are built as native Excel Tables — any future addition automatically inherits the formatting, formulas, and alerts with zero manual work.

• Professional Design

• A main dashboard with quick navigation links to every section
• A unified, bilingual visual identity (Arabic/English)
• Print-ready (fit-to-one-page + automatic pagination)
• Standard color coding for inputs and formulas

Audit-Ready An interconnected structure, unified product identifiers, logically protected input cells, and complete documentation reviewable before SFDA inspectors and regulatory bodies.

•  Value Proposition

Cuts weeks of manual technical documentation down to a ready-made system, reduces compliance errors, and accelerates SFDA approvals — with a rare, professional Arabic design.