Hi,
ISO 13485 requires an organization to define the product lifetime for a device (for record retention time). Our company manufactures IVD instruments (no reagents) the instrument has been out on the market for 10 months and we have sold 23 instruments. The instrument is subject for annual service. In what way can we define the product lifetime for such device.

Hi,
ISO 13485 requires an organization to define the product lifetime for a device (for record retention time). Our company manufactures IVD instruments (no reagents) the instrument has been out on the market for 10 months and we have sold 23 instruments. The instrument is subject for annual service. In what way can we define the product lifetime for such device.How many do you expect to be functioning in 2 years, 5 years, 10 years, 20 years? How long do you want to be responsible for servicing the device? These are the things you should probably consider when determining the product life.