The author describes common challenges in Design Development, and how those problems can be minimized through compliance to FDA requirements for Design Control.
Delivering the innovative solution for pacemaker development in Vitatron
CertiCon designed the intelligent patient information system for online collection and evaluation of data from medical beds.
Attribute sampling is based on the confidence level and quality level. For example, to be 95% confident of a minimum 95% yield, the minimum sample size would be 58.4 units, which is rounded up to 59 units..
Medical device manufacturers usually do not make the component materials that go into their devices, and yet they are responsible for demonstrating that the materials in the devices are safe. Product clinical..
No matter the scope or severity, CAPA is the ultimate catchall for events in the system. This becomes a problem when the "critical" CAPAs - those events that have the most impact on the business as a whole,..
In the focus on meeting the regulatory requirements for Europe and attaining CE Marking, many companies overlook the importance of thorough research and screening of medical device and surgical distributors..