Medical Device Consulting Services by Specialty
Emergo Group provides a full range of medical device and IVD consulting services as shown below. You can also sort our services by country: AUSTRALIA | BRAZIL | CANADA | CHINA | EUROPE | JAPAN | KOREA | MEXICO | RUSSIA | USA
Regulatory Compliance Consulting
- Australia - TGA Medical Device and IVD Registration
- Brazil - ANVISA Medical Device Approvals
- 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
- Brazilian B-GMP Quality System Modification and Certification 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
- Brazil - Registration Holder
Medical Distribution Consulting
- Australia Medical Distributor Search
- Brazil Medical Distributor Search
- Canada Medical Distributor Search
- China Medical Distributor Search
- European Medical Distributor Search
- Japan Medical Distributor Search
- Mexico Medical Distributor Search
- USA Medical Distributor Search
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
