Medical Device Registration with the Australian TGA
Access the Australian medical device & IVD market, get help registering medical devices with the Australian TGA, and use our regulatory compliance consulting.
Obtaining a Medical Device CFG (Certificate to Foreign Government) from FDA
Emergo can help you obtain a CFG (Certificate to Foreign Government) so that you can show proof of FDA compliance in many markets worldwide.
MedSafe Medical Device Registration in New Zealand
Medical device registration service for New Zealand. Get help in obtaining MedSafe approval for your device.
ANVISA Medical Device and IVD Registration and Approval in Brazil
Emergo can assist you with Brazil ANVISA regulatory registration and approval to sell medical devices on the Brazilian market.
MDR and Annex XIV: The Crucial Role of Clinical Evaluation Reports
Learn how to build an MDR compliant clinical evaluation process, the minimum content requirements of the CEP and their implications, the criteria for equivalency and differences with Meddev 2.7/1 Rev. 4.
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RAMS Smart Builder Demo
Quickly and easily create documents for the European Union, U.S. FDA, Brazil and Mexico regulatory affairs submissions.
Clinical Data and Post-Market Compliance Under the MDR
Gain insights from our medical device clinical research team on the role of PMCF studies in MDR compliance and what it takes to conduct a PMCF study that should be acceptable to all stakeholders.
UK MHRA Regulatory Approval for Medical Devices and IVDs: Process Chart
Learn the UK's regulatory approval process for medical and IVD devices, UKCA marking and MHRA registration. Sign up for RAMS and get the first chart free.
Placing Medical Devices on the Swiss Market After the EU MDR Date of Application
Under the European Union's Medical Devices Regulation (MDR), Switzerland is currently considered a third country for medical devices. Find out what that means for manufacturers and importers, and how to safeguard obtain the proper clearance to place Europe