I’d like to have the opinion of this community regarding a project that I have started a year ago to help with the standardisation of open-source hardware (the ORSHARDS project, as the title suggests).
The aim is to create a repository structure dedicated to open hardware that would have the same functionalities as a software repository: storing/sharing projects, providing tools for developers, helping to deploy and to run hardware, keeping track of dependencies for modular items, keeping track of updates/security issues and so on.
Needless to say this project is only starting, but the theory of operation is already in place. I made a gitlab repo with the base ideas but it is private at the moment because I want to make a grant application out of this before I make it public.
If you are interested I’d be happy to give you access. I would also be glad to give access to a GOSH group if there is one of Gitlab, to make things easier.
Thanks!
Actually I made the repo public so you can have a look at the docs. The main branch is pretty empty apart from the docs at the moment but there is another where interesting code is getting written.
The idea is to make it a product lifecycle system management software that could be made complient with ISO13485 and other standards required to put an MRI system in a hospital, because that is what I will be doing for the next few years and I will need such a system.
I am writing up a grant application to get some money to get this done, so if anyone wish to help you are more than welcome!
Making something for ISO 13485 is essential for many projects. I think it will involve multiple repositories. Keeping the design of each device separate from the design group’s quality manual, there also needs to be a record keeping tool (perhaps Git based). But things like changing the quality manual should probably require signed commits and signed tags, and then use a CI to generate the manual with the required revision dates and sign-offs.
It is a project that requires a huge investment of time. We should have another chat at some point.
Yes, I agree that making such a system is going to be a big task. But it is something that has to be done if we want to facilitate access of open source medical hardware to the market, because this is required for CE marking.
It is certainly something I need to build for my own project, and it could benefit many people to make it open.
If there is enough interest for it, I would be really interested to gather a sort of consortium and apply for funding for this project. The current round of EU funding seems like a good candidate if we have several countries interested, but the deadline is in September.
Happy to chat, of course!
I totally agree and I know we have discussed the scale. I was just trying to publicly fend of my urge to try to start another proof of principle program and end up taking on another huge development task as a “side-project”. I have so many side projects now I am not sure I have a front.
Getting the Quality Management and Product Lifecycle right is essential for medical devices, but also for ISO 9001, and for really reliable scientific instruments. As you say we need a consortium, and we need a lot of time and energy to go into this. But it is exciting that we have reached the stage where a number of us are thinking about this!
Actually you got an important point: I do not want to make a separate project if I dont have to. I’d be happy to merge my efforts into any pre-existing similar initiatives if there are some that already exist. I have not found anything similar so far but I’m still looking.
I am currently trying to organise something, hopefully I will get back on the GOSH forum at some point with an annoucement.
I am coming from a research data management perspective, and with real open hardware specialists(Robert Mies TU Berlin/OPENNEXT), we have some funding to go into that same direction (tools to facilitate the documentation and thefefore acreditation of OSH, and their publication)
We have not yet officially started the project, but I see some possible interactions, and would be happy to chat sometime end of august.
I have also been involved in a “standard research folder structure” creation, wich goes in the same direction, but for research projects and without all the iso stuff.
I also wonder whether ELN could be used to be iso compliant, see
Hi @Juliencolomb this sounds really interesting. We’ve been looking to find some funding to support the future development of one of our microfluidic design tools: 3DuF (https://3duf.org).
It solves a ton of the problems with standardization and the ability to transmit all the design details that are usually missed out in traditional publications. I’d love to chat at some point if to see if there’s any potential for supporting the development with the help of feedback from the GOSH community.
Looks like there could be a lot of things to discuss around all these projects. @Juliencolomb: I am thinking to organise a small online workshop in August to bring together people with similar issues and ideas, end of August would be great. Would the 30th or 31st work for you?
I also updated the repository and made it public (this time it should be!).
The repository now has a first package, thanks to the excellent work of a summer student (Baptiste, he may appear in the thread at some point). This is an example package from a regulated power supply project found on Instructables, it is a proof-of-concept that shows how Orshards can faciliate the development work by separating the dissemination from the development, in a way that it similar from software packages that separate the source code from the rest (while the two remain accessible).
