Device Registration
Expert guidance on CDSCO Class A-D medical device classification, ensuring accurate categorization for regulatory submissions.
Clinical Trial Alignment
Strategic protocol alignment for clinical trials, harmonizing evidence generation with local hospital workflows and regulatory expectations.
License & Validation
Streamlined import & manufacturing license approvals and comprehensive testing lab validation support, accelerating market readiness for your medtech innovations.
Indigenous Manufacturing & Quality
Manufacturing plant Setup
Design and implementation of ISO 13485 compliant cleanroom facilities, tailored for medical device production in India.
Local Component Sourcing
Strategic sourcing of local components and materials, optimizing supply chain resilience and cost-efficiency for medtech manufacturers.
Pilot Batch Assembly
Supervised pilot batch assembly and process validation, ensuring scalable and high-quality production before full-scale manufacturing.
Hospital Procurement Pathways
Hospital Pilot Design
Designing effective hospital pilot programs for clinical evaluation, generating real-world evidence for market adoption.
Ethics Committee Clearances
Navigating ethics committee clearances and institutional approvals, ensuring smooth clinical integration and patient safety.
Institutional Procurement
Establishing robust institutional procurement onboarding processes, connecting your device with India's diverse healthcare ecosystem.
Submit your device technical files for a preliminary review and customized advisory proposal.