ISO 13485–Certified Medical Device Manufacturing at Mastars
Background
ISO 13485 is the medical-device quality standard. It embeds risk-based planning, design, and process controls, validation (IQ/OQ/PQ), supplier oversight, traceability, and CAPA. The framework is widely recognized: the EU’s MDR/IVDR and many national regulators acknowledge or reference ISO 13485. For North America and the EU, 13485 is often a market-entry threshold. The standard spans the chain—design and development, component/raw-material supply, sterilization/clean processing, finished-device manufacturing, distribution, and technical services.
ISO 13485 certification
How Mastars Meets ISO 13485 Requirements
- Map risks and controls end-to-end; maintain DMR/DHR and change control.
- Qualify suppliers and materials; enforce incoming checks and traceability.
- Validate special processes (IQ/OQ/PQ); retain verification records.
- Monitor with SPC/MSA; calibrate CMM and gauges on schedule.
Control cleanliness and handling; train staff; close NC/CAPA loops.
From a gynecological speculum client, showing ISO-compliant cleanroom assembly.
Faster, Safer Device Ramps With Certainty
✅ Rapid prototyping accelerates early design and testing.
✅ Lower compliance risk with audit-ready documentation.
✅ Stable quality from validated, monitored processes.
✅ Full lot and serial traceability across builds.
✅ One vendor for NPI, volume, and box-build.
From a breast pump client, Mastars has the ability for full box-build integration.
From Prototypes To Box-Build Applications
- Prototyping: CNC, vacuum casting, 3D printing, sheet metal.
- Molds & Plastics: moldmaking, injection molding, extrusion, silicone/LSR.
- Metals: die casting, CNC machining, MIM, extrusion.
- OEM/ODM: co-development, project management, NPI, assembly.
Virus tube injection mold. Mastars is capable of in-house mold design and machining.
One-stop Manufacturing System for Medical Device
Mastars pairs ISO 13485 controls with a one-stop manufacturing chain—giving small and mid-size medical teams faster prototyping starts and a complete path from raw material and component supply, through sterilization/clean processing and finished assemblies, to distribution and technical service, with stable quality and full traceability.
Clean packaging, sealing, and barcode traceability.
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Mastars, the world's most trusted one-stop small and medium-volume digital manufacturing service provider.
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