Lifetime calculation for Medical Devices

Medical Device manufacturers need to determine the lifetime/Shelf Life of the devices for various reasons. Though for sterile devices stability studies is conducted, for other active devices lifetime of the device needs to be determined. The Lifetime is usually evolved based on individual component life time and holistic view of general degradation due to ageing and exposure to operating environments.

The manufacturer needs to list the Individual lifetime of components and their overall mechanics such as average number of times the component might be used, stroke length , speed, Usage time.The components are also assigned a range of high, medium, low replacement requirements. Based on this calculation, the lifetime of the device is calculated along with the literature reviews on the life expectancy. This is one of the mandatory requirements of CE marking of a medical device and it is best advised to contact an expert in the field who can assist you with your documentation.

The author recommends you to Contact I 3 Consulting for further information and expert knowledge and advice on Medical devices CE marking. Contact jr@i3cglobal.com