Our service
// we offer
Why Will You Choose Our services
regulatory-2

Regulatory Approvals

  • FDA 510(K)
  • CDSCO Medical Devices Registration in India
  • CDSCO Import License
  • CDSCO Manufacturing License
  • CE Marking
  • SFDA
  • UK CA
  • CDSCO Registration for SaMD
  • US FDA Registration for SaMD
  • Veterinary Medical Devices Registration
  • Russia Medical Device Registration
  • BIS Certification
  • Design & Development Documentation
  • Drug Device Combination Products
  • Design History File (DHF)
  • US FDA 21 CFR 820.30 Design Control Requirements
Screenshot_28

Turnkey Project Consultants

  • Product Feasibility & Detail Project report
  • Manufacturing Facility
  • Validation Documentation
  • Clean Room Guidance
  • Quality Management System
  • FDA 21 CFR Part 820 Quality System Regulation
  • ISO 13485 - QMS Medical Device
  • ISO 15378 Certification | Primary Packaging Regulatory Consulting
  • QMS Software (eQMS)
  • MDSAP