Resources
Get the latest white papers, process charts, and other resources about medical device regulatory affairs, quality assurance, human factors, and cybersecurity requirements.
Medical Device Registration in Australia & New Zealand
Thinking about selling your medical device or IVD in Australia or New Zealand? If your device already has CE Marking or approvals in other key
Transitioning to Medical Device Single Audit Program (MDSAP) Compliance
As the first year of its operational phase ends, the Medical Device Single Audit Program (MDSAP) is finally gaining traction among medical device
Medical device registration process in Brazil
Interested in selling your medical device in Brazil? Brazil's device registration process is well established, but rather complex. It's important to
Brazil QMS Requirements For Medical Device Manufacturers
Thinking about selling your medical device in Brazil? If so, you should know that the Brazilian medical device and IVD market is complex. The
Overview of the IVD regulatory landscape in Brazil
Want to sell your IVD in Brazil? Brazil regulators made sweeping regulatory changes in 2015, especially for IVDs. In particular, they consolidated
Preparing a Canadian MDL Application
So you have one or more cleared medical devices in the US and now you want to license them in Canada. While the Canadian registration system seems
Achieving QMS compliance in Canada for medical device and IVD companies
This white paper will discuss the requirements for achieving compliance with the Quality Management System (QMS) regulations as they apply in Canada
China NMPA Medical Device Registration Requirements
Thinking of selling your medical device in China? If so, you need to register your device with China's regulatory authority, the China Food and Drug
How ISO 13485:2016 Impacts Medical Device Companies
The new ISO 13485 revision is finally here and, for medical device manufacturers, this is big news. You probably have plenty of questions about how