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, Mexico 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 - Clinical Evaluation Reports for Medical Devices
- Europe - Medical Device Reimbursement Consulting
- Europe - e-Labeling for Professional Use IVD Devices
- Europe - Packaging Waste Directive and Green Dot Consulting
- Japan - Medical Device Approval and PAL Compliance
- Japan - Device Master File Compilation
- Mexico - Medical Device Registration with COFEPRIS
- 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
- Mexico - Registration Holder
Medical Distribution Consulting
- Medical Distributor Search for Australia
- Medical Distributor Search for Canada
- Medical Distributor Search for China
- Medical Distributor Search for Europe
- Medical Distributor Search for Japan
- Medical Distributor Search for Mexico
- 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
- Clinical Trial Management in Europe
- Medical Device Reimbursement Consulting for Japan
- Validation Consulting - Software, Equipment and Process
