Quality Management System Compliance with Japan Ordinance 169
Emergo can assist medical device companies with QMS compliance including Japan Ordinance 169 and the pharmaceuticals and medical devices Act (PMD Act).
European CE Marking Strategy for Medical Devices
Emergo has a well-established presence in the EU with offices in the UK, Germany, France, and The Netherlands. We have assisted hundreds of medical device manufacturers with CE compliance for Europe.
FDA Submission Consulting for Medical Devices and In Vitro Diagnostics (IVDs)
FDA submission consulting services for medical device and IVD companies. Get help with US FDA registration from Emergo by UL.
ISO 13485:2016 Consulting and Gap Analysis
ISO 13485:2016 is coming! Let Emergo help you transition from ISO 13485:2003 or ISO 13485:2012. Local offices throughout the US, Canada, Europe and Asia.
ISO 14971 Risk Management Consulting for Medical Device Companies
ANSWERED ON THIS PAGE:
What does ISO 14971 require?
How do I implement ISO 14971?
How do I apply the risk management system and concepts to my product?
US FDA Form 483 and Warning Letter Analysis, Response, and Recovery
ANSWERED ON THIS PAGE:
What is an FDA Form 483?
What are the next steps after getting an FDA Form 483?
What is an FDA Warning Letter?
How can you recover from an FDA 483 or Warning Letter?
Global Services
We can help you design and execute a regulatory strategy across major and emerging medical device markets.
Mexico
We provide submission preparation and classification consulting to help companies navigate COFEPRIS requirements.
Brazil
Gain access to one of Latin America's biggest medical device markets with the help of our Brazil-based team.
Japan
Our consulting team in Tokyo delivers local expertise and support for companies seeking PMDA approval in Japan.