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:
CAPA Implementation and Closure
Change Control Management
Supplier Quality Assurance Services
Assisting in Internal/External Audits (as required)