Periodic Review Requirements for Software - Medical DeviceS

During an audit at our medical device company, we got a remark that we had no procedure for 'periodic review' for our computerised systems.

I have found regulatory demands for 'periodic review' in Eudralex vol 4 GMP Annex 11 (Periodic Evaluation) but that is for pharma industri.

Is there any regulatory requirements for periodic review of software in medical device industry - FDA/ISO/EU?

(I have recently moved from pharma to medical device and not yet familiar with all requirements)

Do you mean software as part of the device or software used in your quality system?
If it is device related then as part of the CE certification process and ISO 13485 manufacturers are required to have in place a "systematic procedure to review experience gained from devices in the
post-production phase". I.E. review of complaints, literature searches, studies etc to ensure that the device is safe. This thread will help.
http://elsmar.com/Forums/showthread.php?t=30317&highlight=post+market+surveillance
Rob

I assume you are referring to software used inhouse and not software used as/in a medical device?

FDA has regulation 21 CFR 11 which is for electronic records which may contain something (I 'm just aware of the regulation, not it's contents)

the MDD for europe doesn't require anything like this and there isn't anything explicitly required in ISO 13485; someone being really pedantic may try and argue some non conformance against section 8 regarding measurement, analysis and improvement but it would be difficult to make stick.

To be honest a remark is just that, if it is a non conformance it should be stated as such and written up, if not you can ignore it, possibly also pointing out to them that they should stay within scope