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CAPABILITIES — Regulatory Affairs
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Meeting strict regulatory guidelines is essential in the medical device industry. NDI Medical's regulatory professionals are well versed at steering neurostimulation devices through the sometimes choppy regulatory waters.
Principals of the NDI Medical regulatory team have worked together as a unit for more than a decade and have gained approval for IDE, PMA, HDE, 510k, and CE Mark applications for implantable, percutaneous and surface neurostimulation products and their enhancements.
The regulatory team is led by our vice president of regulatory affairs and quality systems and our quality systems manager. The team's work involves product engineering, design and testing, including identifying international harmonized technical and regulatory standards and conformity testing.
The NDI Medical team maintains quality manufacturing procedures and controls, and it has a deep network of consultants and colleagues who can provide advice, expertise and project work as needed.
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