Quality & Regulatory
Medical Device Businesses need to keep up with a rapidly evolving Regulatory and Quality Assurance Landscape. Businesses can struggle to comply with Regulatory norms across nations, and non-compliance means product recalls or legal costs and can impact brand image.
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NeoDx houses a team of well-qualified and experienced Regulatory Affairs and Quality Assurance Experts who are well-versed in Indian Regulatory norms, US-FDA, and EU regulations.
The expertise offered by our Regulatory team includes:
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Risk Management Services
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Loan Licensing Application Services
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IVDR and MDR Compliance includes CER documentation, Substantial Equivalence, etc.,
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Product Registration per CDSCO, US-FDA, and responding to queries
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Post Approval Change
06
Technical File Documentation and Review
The expertise offered by Our Quality Assurance Team includes:
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QMS Development​
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CAPA Implementation and Closure
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Change Control Management
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Supplier Quality Assurance Services
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Assisting in Internal/External Audits (as required)