European Regulatory Procedures 2017
EMA has a 20-year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the development of medicines. In its first two decades, the Agency recommended the authorization of a total of 975 human and 188 veterinary medicines. EMA's success is based on cooperation within the European medicines regulatory network - a unique partnership between the European Commission,...
Documenting Software for FDA Submissions 2017
When medical device companies consider Agile development methods, they often run into the key criticism that Agile groups produce little to no documentation, and that Agile stands in contradiction to the lifecycle standards outlined in IEC 62304. In fact, those principles - have clear processes for quality management system, risk management process, software maintenance, configuration management, and problem resolution - actually augment rathe...
You must be logged in to view details.
Membership is Free!
Please enter your email and password:
Please sign in with your email and password:
LinkedIn is experiencing technical difficulties. Please log in via email and password. If you do not remember your password, please click "Forgot Password" to reset.