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Quality
As a product development and manufacturing company it is our goal to produce exceptional products.
We understand the quality systems and regulatory compliance issues your company faces. Our Quality
Engineering and Regulatory team can offer design control assistance and regulatory submission support.
Lead Technologies division produces our own Class III active implantable leads. We are ISO-9001:1994/EN
13485:2000 certified, FDA registered, and CE Mark approved.
Delivery systems division produces class II introducers and class III steerable sheaths (Deflectable Catheters). We are ISO 13485:2003 with CMDCAS recognized registrar, FDA registered, CE marked, and ISO 9001:1994 certified. |
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Quality is the focus of every employee at Enpath Medical. |
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Commitment
As a company that provides critical medical technology to patients around the world, we have a
culture that has been built on a strong commitment to quality and customer service. Our motivation
is fueled by the need to improve the welfare of the patient.
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