Relevant case studies

Blog post: 02/10/2025 11:13 am

Author: Spark Team

VR SOP Training for Medical Devices: Class II/III Manufacturing & Assembly

Build procedural precision and traceability with a custom VR training twin

Medical device manufacturers must demonstrate repeatable quality under ISO 13485 and stringent regulatory scrutiny. Spark designs and builds bespoke VR SOP training that replicates your device assembly cells, ESD controls, calibration routines, and DHR/traceability requirements—so operators practise critical steps correctly, first time, every time.

Device manufacturing pain points

• Micro-assembly & ESD: delicate parts, torque settings, ESD zones, and clean handling.
• Validation & calibration: equipment qualification, gauge R&R, and preventive maintenance steps.
• Traceability: component serialisation, UDI, DHR completion, and lot genealogy.
• Change control: introducing ECOs without quality drift or training lag.
• Audit readiness: consistent competence evidence across shifts and sites.

Our bespoke build approach

1. SOP & work instruction capture: break down critical steps, tolerances, and hold points.
2. Digital twin of workcells: fixtures, tools, test benches, and inspection stations.
3. AI avatar coaching: enforces correct tooling, torque sequences, and ESD discipline.
4. Assessment: right-first-time metrics, defect simulation, and visual defect grading.
5. Integration: LMS/QMS connection, multilingual content, and role-based modules.

Commercial & compliance benefits

• Lower scrap/rework through standardised build sequences.
• Faster onboarding for new and temporary staff.
• Clear, auditable competence records for regulators and customers.
• Smoother ECO adoption with minimal disruption.

Why Spark

We tailor VR training to your devices, fixtures, gauges, and SOPs—no generic modules, just a build that matches reality on your line.

Explore a custom VR SOP trainer for your device line. Contact Spark.

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