Monthly Archives: May 2023

During this 3-day training, learn how to develop and validate medical device software in an ever-changing landscape of regulations and technology. This class will ground you in all the relevant regulations, standards and guidance and help you understand how risk, cybersecurity, cloud computing and mobile apps impact the medical device software space.  It will also [...]

The regulatory pace of change is accelerating for the in-vitro diagnostics (IVD) industry. Evolving regulatory standards impact IVD manufacturers, central laboratories, contract research organizations and manufacturers who bring new IVD devices to the commercial market or sponsor drug or medical device clinical trials that utilize IVD products as part of trial conduct. The In-Vitro Diagnostic [...]