Medical Device Regulatory Compliance Consulting

Emergo Group provides a full range of medical device and IVD consulting services as shown below. 

Jump directly to:  AUSTRALIA | CANADA | CHINA | EUROPE | JAPAN | UNITED STATES

EUROPE

• EU Authorized Representative
• CE Marking Consulting for Medical Devices and CE Mark Training
• Technical File Preparation for Medical Devices and IVD
• ISO 13485 Quality System Implementation and ISO 13485 Auditing
• European Packaging Waste Directive Compliance & Green Dot Consulting

UNITED STATES

• FDA 510(k) Preparation for Medical Device Clearance
• FDA GMP Quality System Implementation
• FDA GMP Audits and GMP Training
• US FDA Agent Representation

JAPAN

• Quality System Consulting to Meet Japan MHLW Ordinance #169
• Independent Marketing Authorization Holder (MAH) Representation
• Medical Device Approvals & Registration in Japan
• Device Master File Creation - Seihin Hyojun Sho
• Japan Medical Device Reimbursement

CHINA

• Chinese SFDA Medical Device Approvals
• Legal Agent and After Sales Agent Representation
• CCC Mark Certification

AUSTRALIA

• Australian TGA Sponsor Representation
• Medical Device and IVD Registration in Australia

CANADA

• Medical Device License (MDL) & Medical Device Establishment License (MDEL)
• ISO 13485:2003 Quality System Implementation, Audits or Training
• Canadian Medical Device Regulations (CMDR) Consulting

Emergo maintains these websites:

EmergoGroup.com - Complete list of quality assurance and regulatory compliance services.

FDA510k.com - Information on obtaining FDA approval to sell a new medical device in the USA.

AuthorizedRepresentative.com - Information on Authorized Representative services for medical device companies.

GreenDotCompliance.eu - Helps companies in all industries meet the European Packaging and Packaging Waste Directive requirements.