Impact of the MDR on Quality Management Systems (QMS), technical documentation, clinical trial requirements, UDI and combination products.
It will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD.
Non-clinical laboratory studies in which tests article are studied in test system under laboratory conditions to determine their safety.
The entire HIPAA Security Rule and uncover simple methods to comply and create policy.
The intent was to avoid creating a huge regulatory compliance cost to industry that was initially preventing companies from embracing the technology.
It will help to comply with regulatory requirements with minimized overhead and resource burden.