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 device company and as of yet, have no samples to retain. Is there a requirement to retain a certain amount of samples...

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 in the ISO text, what's really new ? we received an e-mail from our …

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 external documents as this pertains to copyrighted materials such …

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 ourselves from D&D, but I'm now wondering with the expansion in scope, should we include D&D with respect to the components we design and manufacture, even though the initial concept may ...

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 differentiate without having access to a definitions standard am I correct to say that "exemptions" are for when a whole section...

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 shall retain the records for at least the lifetime of the medical device as defined by the organization, or as specified by...

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 any adverse effect of the rework upon the product prior to authorization and approval 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 perform at that location. Any change in location will have to be re-assessed for the effective performing of the stated scope.

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 ISO13485, but have an issue over supplier management. We currently have supplier groups for General, Aerospace Production, Stockists, Engineering & Nuclear.