Medical Device Consulting Services by Specialty

Emergo Group provides a full range of medical device and IVD consulting services as shown below. If you prefer, see our consulting services related to Australia, Canada, China, Europe, Japan or the USA.

Regulatory Compliance Consulting

• Australia - TGA Medical Device and IVD Registration
  
• Canada - Medical Device Regulations (CMDR) Consulting
• Canada - License Applications
  
• China - SFDA Medical Device Registration & Approval
• China - CCC Mark Certification Approval
  
• Europe - CE Mark Consulting for Medical Devices and IVD
  
• Europe - Technical File Preparation for Medical Devices and IVD
• Europe - Packaging Waste Directive and Green Dot Consulting
  
• Japan - Medical Device Approval and PAL Compliance
  
• Japan - Device Master File Compilation
• US - FDA 510(k) Clearance for Medical Devices
• US - FDA 513(g) Preparation
  
• Worldwide - Medical Device Classification Consulting
• Worldwide - Outsourcing of Regulatory Affairs and Compliance
• Worldwide - Summary Technical Document (STED) Preparation
• Worldwide - ISO 14971 Medical Device Risk Management Consulting

Quality Management Consulting

• US FDA GMP (Good Manufacturing Practice) Implementation
• ISO 13485 Quality System Implementation Consulting
  
• Ministerial Ordinance #169 Quality System PAL Compliance for Japan
• Quality System Audits for ISO 13485:2003 and FDA GMP
• US FDA Form 483 & Warning Letter Response and Recovery
• Outsourcing of Quality Assurance (QA) Activities

Global (In-Country) Representation

• Europe - Authorized Representative
• United States - US FDA Agent
• Japan - Designated Marketing Authorization Holder (MAH)
• Australia - TGA Sponsor
• China - Legal Agent and After Sales Agent

Medical Distribution Consulting

• Medical Distributor Search for Australia
• Medical Distributor Search for Canada
• Medical Distributor Search for Europe
• Medical Distributor Search for Japan
• Medical Distributor Search for the USA

Training

• CE Marking Training
• Internal Auditor Training - ISO and GMP
• ISO 13485 Training
  
• ISO 14971 Training
• US FDA GMP Training

Other Consulting Services

• Clinical Trial Consulting in Australia
• Clinical Trial Management in China
• Medical Device Reimbursement Consulting for Japan
• Validation Consulting - Software, Equipment and Process