All QA/RA Services
Emergo Group provides a full range of medical device and IVD consulting services as shown below. All of these links will send you to EmergoGroup.com, our main website.
Australia
Canada
- Medical Device Licenses (MDL & MDEL)
- ISO 13485:2003 Quality System Implementation, Auditing and Training
- Canadian Medical Device Regulations (CMDR) Consulting
- Medical Distributor Search and Qualification for Canada
China
- SFDA Medical Device Approval
- Legal Agent and After Sales Agent Representation in China
- CCC Mark Certification
Europe
- Authorized Representative (EC REP) for Medical Devices
- CE Marking Consulting and Training for Medical Devices and IVD
- ISO 13485:2003 Quality System Implementation, Auditing and Training
- Medical Distributor Search in the EU
- Technical File Preparation
Japan
- Designated Marketing Authorization Holder (D-MAH)
- PMDA Medical Device Approvals and Pharmaceutical Affairs Law (PAL) Compliance
- Medical Distributor Search in Japan
- Quality System Consulting to Meet Japan MHLW Ordinance #169
- Medical Device Reimbursement Consulting for Japan
Mexico
- Medical Device Registration and Approval in Mexico
- Registration Holder Representation in Mexico
- Mexico Medical Distributor Search
Russia
United States
- FDA 513(g) Consulting for Products with No Clear Predicate Device
- FDA GMP Quality System Implementation Consulting, Audits and Training
- Medical Distributor Search in the US
- Outsourcing of Quality Assurance & Regulatory Affairs Tasks
- US Agent Representation to the FDA
- Validation Consulting for Processes, Equipment and Software
