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Enpath Medical Lead Technologies has an ISO 9001/EN46001 certified, FDA registered, and CE compliant manufacturing facility with 26,000 square feet of manufacturing, laboratory, and office space. In addition, 5000 sq. ft. of that space is dedicated to Class 10,000 clean room product assembly and sterile packaging. Enpath Medical Lead Technologies also has extensive labeling capabilities and warehousing for strategic sourcing and final shipment. For processing specialized components in the manufacture of implantable stimulation leads, Enpath Medical also has the unique advantage of being able to leverage our in-house laser capabilities. Like the spectrum of contract development services, Enpath Medical can provide any or all of the manufacturing services listed below:
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Complete manufacturing transfer of your existing product lines |
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Concurrent manufacturing engineering for products in the development stage |
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Design, fabrication, and validation of tooling and fixtures |
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Manufacturing process development and validation |
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Sterilization, shelf life, and packaging validation |
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Qualification and clinical trial samples |
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FDA submission support and documentation |
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Full-scale production |
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Complete packaged product with ship-to-stock service |
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