May 14, 2008 · Hello all, just a quick query.l am writing up a control of Quality Records procedure and under the heading of sample retention, i have hit a block. We are a start up medical …

Nov 28, 2016 · Dear all , As you know ISO 13485:2016 now contains a clause about technical file of the medical device (clause 4.2.3). As part as this requirement has been newly written down …

Jul 31, 2006 · Re: Identification & Control - Documents of External Origin - ISO13485:2003 Clause 4. I have a question regarding the requirement for controlling the distribution of …

Aug 15, 2017 · I am currently adopting ISO13485: 2016 for our company. We're a component supplier to the Medical Device sector and also an OEM supplier. We currenly exempt …

Aug 14, 2017 · Good morning, Our CB auditor said something during his last audit about separating out the exempted requirements from those that are not applicable. Trying to …

Jan 21, 2025 · Dear Elsmar Team, We are in the process of moving to a different site and we are thinking of shredding documents we don't need. ISO 13485 Requirement: The organization …

Apr 19, 2004 · When I reviewed ISO13485 Part 8.3, an interesting deviation found when compare with QSR 820.90. If, rework is needed, based on ISO13485, we shall have a determination of …

Apr 2, 2019 · Contact your CB well in advance and with a date plan of probable effective change. The location as in your ISO13485 certificate concerns to the scope and processes that you …

Aug 25, 2021 · While creating a deviation SOP, I'm trying to find what ISO13485:2016 standard fits best for deviations as a reference. Thanks

Mar 1, 2012 · We are an aerospace company developing a medical product for military use. We are busy adapting and modifiying our management system to meet the requirements of …