R
raqamanager
Hello users,
I work for a company which is developing an IVD medical device comprising a PCR based assay. We are ISO9001:2008 and ISO13485:2003 certified. We are using an automated liquid handling robot in the research and development phase to try and replicate the assay conducted by technicians. It is our intention that the assay to be sold commercially is conducted using an automated liquid handling robot.
I am confused about the regulatory implications of determining performance characteristics using the robot and specifying these performance characteristics in a CE submission. If we use the robot for determining performance characteristics are we limiting ourselves to selling an assay which can only be used using a liquid handling robot or can it be used using normal 'Gilson' type pipettes?
Many thanks
I work for a company which is developing an IVD medical device comprising a PCR based assay. We are ISO9001:2008 and ISO13485:2003 certified. We are using an automated liquid handling robot in the research and development phase to try and replicate the assay conducted by technicians. It is our intention that the assay to be sold commercially is conducted using an automated liquid handling robot.
I am confused about the regulatory implications of determining performance characteristics using the robot and specifying these performance characteristics in a CE submission. If we use the robot for determining performance characteristics are we limiting ourselves to selling an assay which can only be used using a liquid handling robot or can it be used using normal 'Gilson' type pipettes?
Many thanks