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Hi Vikram, Reading your posts it seems you have a complicated case - I'll try to elaborate below. If my assumptions are incorrect I apologize. It seems to me, that you have a few separate issues - I recommend to split up your case into as many minor issues as possible, and then manage eat issue individually ...

Hi Vikram, Your question is not entirely clear to me - so you'll get some comments and return questions. I assume that with 'Product Design Life' you refer to 'expected service life' as defined by clause 3.28 of IEC 60601-1? This term relates to the time period during which the device is expected ...

Hi, Yes, according to IEC 60601-1-2 4th edition, you are to identify which phenomena / tests are applicable to your device. For a battery powered device, with no physical in-/out-put ports, the minimum tests are quite limited, as you can only test the enclosure port. As a manufacturer, it is your ...

Hi Sheeman, For EN 60601-1 ed. 3.1 the date of cessation of presumption of conformity of superseded standard was 31/12-2017. As such, per 01/01-2018 compliance with ed. 3.0 is not sufficient to provide presumption of compliance, as that version of the standard is no longer harmonised. It is ...

Hi Naveen, Thank you for sharing your slides. My personal thinking is, that: Yes, Big Data and related technology is going to play a big role for the industry, but I do not think it will happen right know. The challenge of utilizing data in a meaningful way is enormous – and it ...