ISO 13485 Compliance with V5 – Digital Quality for Medical Device Manufacturers
V5 from SG Systems Global empowers medical device manufacturers to meet ISO 13485 requirements through enforceable digital systems. From production control to quality assurance and traceability, V5 supports every clause with real-time data capture, automated validation, and audit-ready documentation. Built. Tracked. Compliant.
With integrated MES, WMS, and QMS modules, V5 digitizes ISO 13485 compliance into every task—eliminating paper, closing training gaps, enforcing device history records, and increasing production efficiency without compromising regulatory control.
“V5 made our ISO 13485 audit feel like a formality. Everything was documented, locked, and traceable.”
— VP of Compliance, Class II Medical Device Manufacturer
Clause-by-Clause Enforcement of ISO 13485
V5 enforces the core ISO 13485 clauses with real-time controls, digital signatures, and escalation logic:
- Clause 6.2 – Personnel Competence: Prevents untrained operators from accessing regulated tasks
- Clause 7.4 – Purchasing: Supplier approval and material quarantine built into WMS
- Clause 7.5 – Production & Service Provision: Enforced production steps, in-process control, and electronic records
- Clause 7.6 – Calibration: Blocks use of uncalibrated instruments and enforces calibration intervals
- Clause 8.3 – Nonconforming Product: Integrated NCR workflows with QA holds and disposition tracking
- Clause 8.5 – CAPA: Root cause analysis, escalation timers, and corrective action tracking
- Clause 4.2 – Documentation Control: Version-controlled SOPs, enforced reviews, and digital signoff
DHR, DMR & Traceability – Automated and Audit-Ready
V5 builds the Device History Record (DHR) automatically during production, ensuring alignment with the Device Master Record (DMR):
- Operator actions logged in real time with timestamps and electronic signatures
- Material usage traced back to suppliers, lot numbers, and inspection records
- Process deviations escalated for QA review and approval
- Review-by-exception tools accelerate QA batch release
- All data accessible for internal or external audits at any time
Every record is sealed, reviewable, and defensible—whether you’re supplying diagnostics, implants, or sterile kits.
“With V5, we built a living DHR. It grows with the batch—and it’s always ready to review.”
— Director of QA, Surgical Device Manufacturer
Production Control Beyond the Basics
ISO 13485 isn’t just about the batch—it’s about the environment, equipment, and people. V5 enforces every layer of operational control:
- Line Clearance Checklists: Digitally verified area clearance before batch start
- Asset Calibration Status: Only allows use of calibrated balances, scanners, and tooling
- Operator Training: Role-based access tied to training records and expiry dates
- Environmental Logs: Temperature, humidity, and pressure linked to batch records
- Job & Location Based Checklists: Sanitation, pre-op, cleaning, and tooling confirmation
Nothing moves unless every step, person, and asset is verified. That’s traceability in action.
Global Standards, Built-In
Whether you’re preparing for FDA inspection, CE Marking, or MDSAP audit, V5 supports ISO 13485 and adjacent standards:
- Supports ISO 13485, 21 CFR Part 820, EU MDR, MDSAP, and Annex 11
- Validated against GAMP 5 with documentation package
- Includes electronic signature controls for Part 11 compliance
- Cloud or on-premise deployment options with secure data controls
- Used in Class I, II, and III medical device manufacturing worldwide
Explore how each V5 module supports ISO 13485 compliance:
