Resources
All regulatory process charts are available to download in Regulatory Affairs Management Suite (RAMS). Get your first chart for free when you create a RAMS account.
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
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
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
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
Cleaning, disinfection, and sterilization of reusable medical devices
Cleaning, disinfecting, and sterilizing medical devices are critical activities for preventing the incidence of healthcare associated infections (
PMS & PSUR requirements under the EU MDR
Medical device post-market surveillance (PMS) activities have already been described in the European Medical Device Directive (93/42/EEC) and are
MDR One-year Delay: Implications for medical device manufacturers
In February 2020, the first European countries began to be affected by the COVID-19 virus. During March, the rest of the pack followed and Europe