Medical Component Testing & CertificationGlobal Business Development, LLC supports firms pursuing regulatory and performance validation for medical components through:

• Coordination of independent laboratory testing (durability, biocompatibility, sterilization)
  
• Development of regulatory documentation for:
  
  • FDA 510(k) submissions (U.S.)
    
  • CE marking / EU MDR (European Union)
    
  • Health Canada licensing (Canada)
    
  • TGA conformity (Australia)
    
  • ANVISA registration (Brazil)
    
  • UKCA marking (United Kingdom)
    
• Support for risk management files (ISO 14971) and clinical evaluation reports
  
• Guidance on post-market surveillance and product lifecycle requirements
  

Remote Office & Facility ComplianceAssistance for organizations managing distributed or expanding operations:

• Registration of remote offices and warehouses for state/local compliance
  
• SAM.gov and SBA updates for relocated or additional locations
  
• Evaluation of tax nexus, local permitting, and labor compliance
  
• Support for international agent/distributor registrations where required
  

Technical File & Global Quality DocumentationSupport for manufacturers preparing to enter regulated markets:

• Creation and maintenance of:
  
  • Technical Files (EU MDR, UKCA)
    
  • Design History Files (DHF) and Device Master Records (DMR)
    
  • UDI submission and GUDID entries
    
• Gap assessments for:
  
  • ISO 13485 (Quality management systems for medical devices)
    
  • ISO 10993 (Biological evaluation)
    
  • MDSAP audit readiness (for global recognition)