Feb 4, 2020 · Can someone please suggest the best suitable QMS software for medical device startups? I mean something that meets requirements as per ISO 13485:2016 and is not so expensive.

Nov 9, 2020 · Hi everyone, While implementing the QMS, it was brought up to the table the feasibility of pursuing a QMS software. At least from the get-go, to control the following elements: - Document …

Aug 24, 2009 · Re: AS9115 is being balloted - AS QMS Standard for deliverable software Thanks for the info. I've been telling software people that this was in the works for quite some time. Hopefully it will …

Jun 12, 2019 · Was wondering if any one is building their QMS in SharePoint to house their Document control, audit system, CAPA etc.? if so, how do you have it set up...

Jun 16, 2022 · Hi All, Is Software Validation required for the Software used for design and development like Solidworks, Catia Etc. According to ISO 13485 clause 4.1.6. it states software validation required …

Potential Audit Questions: 1. Explain your process for ensuring the control, calibration and maintenance of inspection, measuring and test equipment (including test software) that is used by your company …

Apr 2, 2020 · Hello, Can anyone please provide a general SOP for software validation of all quality related software/s. Also can anyone please inform, what validation/verification tests can be written for …

Jan 17, 2024 · Can you suggest any good eQMS software for a start-up medical device company ? There are plenty of eQMS softwares and its hard to shortlist. I am looking for reasonably priced …

Dec 20, 2004 · anyhow, i would like to ask if anyone knows where i can acquire open-source or freeware QMS software tools (ie document control, ncr tracking, etc.)

May 13, 2016 · Re: Software Validation – Clause 4.16 of ISO 13485:2016 Hi Steve, Sounds like you are further ahead than me on this. I did start to think about this, specifically the use of spreadsheets, as …