Services

What we Offer

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
  
• 
  BIS Certification
  
• 
  Design & Development Documentation
  

• 
  Drug Device Combination Products
  
• 
  Design History File (DHF)
  
• 
  US FDA 21 CFR 820.30 Design Control Requirements
  

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
  

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