Your gateway to the health industry
Emergo Australia Pty Ltd
Emergo Group provides a full range of medical device and IVD consulting services as shown below.
AUSTRALIA
- Australia Medical Device and IVD Registration
- STED Preparation for Australian Medical Device Approvals
- ISO 13485:2003 Quality System Implementation or Modification
- Australia Clinical Research Consulting
- Australia Medical Distributor Search
BRAZIL
- Medical Device Registration with ANVISA
- BGMP Quality System Compliance
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 Audits
- Canada Medical Distribution Consulting
CHINA
- SFDA Medical Device Approvals
- Legal Agent and After Sales Agent Representation
- Chinese Medical Distributor Search
- Clinical Trial Consulting and Clinical Research in China (CRO)
EUROPE
- Authorized Representative (EC REP)
- CE Marking Consulting for Medical Devices and IVD
- Technical File Preparation for Medical Devices and IVD
- Clinical Evaluation Reports for Medical Devices
- Medical Device Directives and CE Mark Training
- ISO 13485 Quality System Implementation and Auditing
- EU Medical Device Reimbursement
- Online eLabeling Service for Professional Use IVD Products
- European Medical Distributor Search
- Risk Management & Risk Assessment Consulting
JAPAN
- Japan Quality System Consulting to Meet MHLW Ordinance #169
- Independent Marketing Authorization Holder (MAH)
- PMDA Medical Device Approvals and Pharmaceutical Affairs Law (PAL) Compliance
- Device Master File Creation for Japan
- Japan Medical Distributor Search
- Medical Device Reimbursement in Japan
MEXICO
- Medical Device Approval in Mexico
- Registration Holder Representative
- Distributor Search and Qualification
RUSSIAN FEDERATION
- Medical Device Registration in Russia
- GOST-R Certificate Coordination
- Hygiene/Sanitary Certificate Coordination
UNITED STATES
- FDA 510(k) Clearance for Medical Devices
- FDA GMP Quality System Implementation Consulting
- US FDA Agent Representation
- US Medical Distributor Search
- FDA GMP Overview Training and Audits
- ISO 14971:2007 Risk Management
- Validation Consulting for Processes, Equipment and Software
| Address |
201 Sussex Street, Darling Park, Tower II, Level 20 Sydney NSW 2000 |
| Tel | +61 (0) 2.9006.1662 |
| Website | www.emergogroup.com |