ISO 13485 (Medical)

Medical Quality for Patient & Provider Safety

ISO 13485

The safety and quality of our medical products is of the highest importance at Boyd Corporation which is why we are certified with ISO 13485 at our medically focused facilities. Medical wearables, medical disposables, medical devices, test equipment, sensitive instruments, and in vitro diagnostic devices (IVD) all require stringent Quality Management Systems (QMS) to ensure reliable performance and cleanliness.

ISO 13485 is based on the ISO 9001 Quality Management System with an additional focus on regulatory compliance which requires more thorough documentation. Solutions manufactured in Boyd’s ISO 13485 are produced in a controlled work environment that adhere to strict inspection and traceability documentation. With Boyd’s ISO 13485 certifications, you can be sure that we are bringing the best quality standards to your medical products.

Boyd’s ISO 13485 facilities take ISO 9001 quality controls to the next level with more thorough documentation and stricter process controls. Boyd adheres to ISO 13485 through each step of our solutions’ life cycle from material sourcing, fabrication and assembly to sterile kitting. To ensure we produce safe solutions, we utilize clean room environments, strict processes and constant quality assessment in our work environments.

Boyd Corporation’s ISO 13485 (Medical) by Location:

Clean Room Assembly for Medical Devices

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