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MDS-REQ 10 & ISO 13485
SFDA Inspection & Quality-System Readiness
Inspection Readiness Requires Objective Evidence, Not Only SOPs. SFDA maintains requirements for inspections and quality management systems for medical-device establishments and manufacturers. Inspection readiness should demonstrate that documented controls are actually implemented and can be traced through records.
When This Support Is Needed
Preparing for an SFDA on-site regulatory audit or establishment inspection in Saudi Arabia
Aligning quality management procedures with SFDA requirements under MDS-REQ 10 and ISO 13485
Undergoing an inspection of warehouse storage, distribution facilities, or Authorized Representative operations
Responding to formal inspection observations, non-conformities, or corrective action requests from the SFDA
What We Challenge Before Submission
Can the organization demonstrate active, controlled implementation through records rather than written SOPs alone?
Are design and manufacturing changes systematically traced back to risk management file updates?
Are supplier quality controls and audits commensurate with the critical risk level of supplied components?
Are customer complaints and tecnovigilance reports consistently feeding CAPA investigations?
Can personnel comfortably explain outsourced processes, warehouse controls, and calibration records during an SFDA audit?
Our Inspection & QMS Readiness Scope
Quality Management System (QMS) gap assessment against MDS-REQ 10 and ISO 13485
Document and record-control readiness (Device Master Records, Device History Records)
Design and development control evidence review (Design History Files)
Risk management implementation and post-production feedback loops (ISO 14971)
Purchasing controls, critical supplier evaluations, and incoming inspection records
Process validation, cleanroom environmental monitoring, and sterilization records
Customer complaint handling, technical investigation, and vigilance reporting records
Corrective and Preventive Action (CAPA) system effectiveness review
Management of change (MOC) and design change control implementation records
Internal audit and executive management review readiness
Mock inspection, personnel interview coaching, and audit war-room preparation
Response drafting, root cause analysis, and CAPA submission for SFDA inspection findings
Audit Readiness Test:
Our inspection question is simple: if SFDA follows one real device, complaint, change or supplier issue through your system, can the organization demonstrate consistent, controlled and effective implementation?
Prepare for SFDA Regulatory Audits with Expert Inspection Coaching
Our quality system auditors conduct mock inspections, remediate MDS-REQ 10 gaps, and resolve inspection findings.