ISO 13485 Certified Sewing Services
At Fieldtex, we support medical device manufacturers with ISO 13485-compliant sewing services and the documentation required to meet regulatory standards. With decades of experience sewing for the medical industry, we understand the importance of traceability, calibration, and process control.
What is ISO 13485 and Why It Matters
ISO 13485 is the global standard for quality management systems specific to medical devices. When sewn components like garments, straps, or enclosures are part of a Class II or Class III medical device, documentation and manufacturing controls must meet ISO 13485 standards. We specialize in manufacturing sewn components that meet these requirements and can provide the documentation your regulatory team needs.
When is ISO 13485 Documentation Needed?
Not all sewn parts need to be ISO 13485-compliant. For example, if we're producing a soft carrying case or holster that's not considered part of the functioning device, ISO 13485 may not apply. However, for Class II and III devices where sewn parts are integrated into the final product, compliance is essential. We currently manufacture garments and other components that fall into this category.
Equipment Calibration & Validation
All relevant sewing and cutting equipment used in ISO 13485-compliant production is calibrated on a set schedule, with records available for customer review. We also follow validated processes for critical operations to ensure consistent output.
Documentation & Quality Controls We Provide
We help simplify the compliance process for our customers by providing:
These records are maintained in accordance with ISO 13485 documentation standards.
Lot Traceability
AWe track materials from incoming inspection through final production. Each production lot is linked to its raw material batch, operator, and final inspection data—supporting full traceability for audits and corrective actions.
Quality Testing & Final Inspections
Depending on the application, we can perform or coordinate various tests to confirm the performance of sewn parts. Final inspections are documented and available to support your DMR or DHF requirements.Ready to Support Your ISO 13485 Compliance
We’re already doing this work for medical customers today—and we’re ready to support your project too. Whether you need a fully documented manufacturing process or just want to understand your options, we’re here to help.
Learn more about our Medical Sewing Services or Contact Us to discuss your compliance needs.