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Capability

QMS (ISO 13485)

Suppliers
1
States & provinces
1
Countries
1

1 qms (iso 13485) supplier across 1 states and provinces in 1 country. Profiles show capabilities, materials, certifications, and facility locations so you can compare shops and build a shortlist.

Suppliers

EEA INNOVATIONS, LLC

KNOXVILLE, TN

EEA Innovations specializes in medical device development, delivering engineering, regulatory, testing, and commercialization services. With over two decades of experience, the team has developed 10+ FDA-cleared products and operates within a QMS aligned with ISO 13485 and IEC 62304, partnering with innovators to fast-track medical technologies, software, and devices from concept to commercialization.

3D printingbiological evaluation (ISO 10993)design for manufacturingdesign transferEMC safety testingmachiningmedical device developmentmoldingpackaging designpackaging validationprocess validationrapid prototypingregulatory strategyrisk management (ISO 14971)software development (IEC 62304)sterilization validationsupplier qualificationusability testing (IEC 62366)verification and validation

Compiled from public sources

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