top of page

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.

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:


Risk Management Services


Loan Licensing Application Services


IVDR and MDR Compliance includes CER documentation, Substantial Equivalence, etc.,


Product Registration per CDSCO, US-FDA, and responding to queries


Post Approval Change


Technical File Documentation and Review

The expertise offered by Our Quality Assurance Team includes:

  1. QMS Development​

  2. CAPA Implementation and Closure

  3. Change Control Management

  4. Supplier Quality Assurance Services

  5. Assisting in Internal/External Audits (as required)

NeoDx gives you the Right expertise to navigate Indian Medical Devices and other Regulatory Compliances.

bottom of page