Hi, I hope you can just help me out here - We have a medical device that we are going to attach sensors to which will then link to some software. As well as the product having to conform to the requirements of ISO13485 and the medical devices directive for CE marking. Does anyone know what software regulations I will need to comply with if any and also is there an invivo diagnostic regulation. I dont mean invitro, as the test will be done whilst the device is in the human body. Finally, does anyone know the definition of "an active implantable device" as I dont have a copy of the ISO14708 and I am not sure whether we need to go this route anyway. OK thanks in advance for any help that is forthcoming. Great site by the way.........

Hi, I hope you can just help me out here - We have a medical device that we are going to attach sensors to which will then link to some software. As well as the product having to conform to the requirements of ISO13485 and the medical devices directive for CE marking. Does anyone know what software regulations I will need to comply with if any and also is there an invivo diagnostic regulation. I dont mean invitro, as the test will be done whilst the device is in the human body. Finally, does anyone know the definition of "an active implantable device" as I dont have a copy of the ISO14708 and I am not sure whether we need to go this route anyway. OK thanks in advance for any help that is forthcoming. Great site by the way.........The definition can be found in the directive, 90/385/eec, for active implantable medical devices. (a) ‘medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, together withany accessories or software for its proper functioning, intended by the manufacturer to be used for human beings in the:
— diagnosis, prevention, monitoring, treatment or alleviation of disease or injury,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception, and which does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic means, but
which may be assisted in its function by such means;
(b) ‘active medical device’ means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity;
(c) ‘active implantable medical device’ means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure; I don't know which standard for software would apply in your situation, but IEC 60601-4, is used for Programmable medical electrical systems. You can look at the list of directives & harmonized standards (http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist.html) and then consult your notified body for a final determination as to which standard they would require, for you to satisfy the essential requirements outlined in the directive(s).

Al, once again many thanks for the help. Just after I posted the original thread I located the ec directive also. But thanks anyway. I followed your link which was useful, but during the search I came across another link which has been extremely useful. I am going to include it here for others if that is ok. http://www.12207.com/Medical%20standard.htm It lists down many of the relevant software standards that are applicable to medical devices - all on one page with examples attached. So big thanks once again. Best wishes.

Al, once again many thanks for the help. Just after I posted the original thread I located the ec directive also. But thanks anyway. I followed your link which was useful, but during the search I came across another link which has been extremely useful. I am going to include it here for others if that is ok. http://www.12207.com/Medical%20standard.htm It lists down many of the relevant software standards that are applicable to medical devices - all on one page with examples attached. So big thanks once again. Best wishes.Thanks for the link!