QA/RA Medical Device & IVD Consulting Services by Country/Region
Emergo Group provides a full range of medical device and IVD consulting services as shown below. If you prefer, view a list of our QA/RA medical device consulting services grouped by specialty including Quality Assurance, Regulatory Compliance, In-Country Representation, Distribution Consulting and Training.
Go directly to QA/RA consulting services for: AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | USA | WORLDWIDE
AUSTRALIA
- Australian TGA Sponsor Representation
- Australia Medical Device and IVD Registration
- STED Preparation for Australian Medical Device Approvals
- Australia Clinical Research Consulting
- Australia Medical Distributor Search
CANADA
- Medical Device License (MDL) & Medical Device Establishment License (MDEL)
- ISO 13485:2003 Quality System Implementation or Modification
- Canadian Medical Device Regulations (CMDR) Consulting
- ISO 13485 Training
- ISO 13485:2003 and CMDR Pre- and Post-Certification Audits
- Canada Medical Distribution Consulting
CHINA
- SFDA Medical Device Approvals
- Legal Agent and After Sales Agent Representation
- CCC Mark Certification
- Clinical Trial Consulting and Clinical Research in China (CRO)
- English to Chinese Translation for Medical Device Documentation
EUROPE
- Authorized Representative (EC REP)
- CE Marking Consulting for Medical Devices and IVD
- Technical File Preparation for Medical Devices and IVD
- Medical Device Directives and CE Mark Training
- ISO 13485 Quality System Implementation Consulting
- ISO 13485 Auditing
- European Medical Distributor Search
- Risk Management & Risk Assessment Consulting
- Packaging Waste Directive Compliance & Green Dot Consulting
JAPAN
- Japan Quality System Consulting to Meet MHLW Ordinance #169
- Independent designated Marketing Authorization Holder (MAH)
- PMDA Medical Device Approvals and Pharmaceutical Affairs Law (PAL) Compliance
- Device Master File Creation for Japan - Seihin Hyojun Sho
- STED - Summary Technical Document Compilation
- Japan Medical Distributor Search
- Medical Device Reimbursement in Japan
- English to Japanese Translation for Medical Device Documentation
UNITED STATES
- FDA 510(k) Clearance for Medical Devices
- FDA cGMP Quality System Implementation Consulting
- US FDA Agent Representation
- US Medical Distributor Search
- FDA GMP Overview Training
- FDA GMP Quality System Audits
- FDA Form 483 or Warning Letter Response
- FDA 513(g) Consulting for Medical Devices
- ISO 14971:2007 Risk Management
- Validation Consulting for Processes, Equipment and Software
WORLDWIDE (Services that apply to many countries)
- Quality System Audits and Gap Analysis
- Due Diligence Audits to Determine QA & RA Compliance
- Internal Auditor Training (ISO 13485 and FDA QSR)
- ISO 13485 Quality Management Systems Consulting
- ISO 13485 Training
- ISO 14971 Risk Management Consulting
- ISO 14971 Training
- Medical Device Classification Consulting
- Quality Assurance & Regulatory Affairs Outsourcing
- Software, Equipment and Process Validation Consulting
