[Open Design + Hardware] regulatory issues

Mon Oct 7 13:10:11 UTC 2013

Hello Laura & List members,

Thanks loads for the link to the OSHW discussion- currently swamped with thesis writing so missed this.
I have *just* finished a final(ish) draft of a co-authored paper on open design & standards, in which a colleague of mine and myself interviewed 2x representatives of the British Standards Institute (BSI) about open design, and who/how/when standards could/should apply.

We're just tidying up the language & then it's good to go- we're looking at some open-access design journals to put it in; we'd love to just release it now, but we're both doing PhDs so need to make sure this work 'counts'- but we're eager the community gets to look at it (by not being behind a paywall).

Personally, I've been working on this issue myself with medical products- how does distributed manufacturing & open design work, when you have to work through the FDA 501K process… or have your medical device ratified by a Notified Body to get a CE mark in the EU?

As it turns out, it makes some aspects of the processes easier- some much harder.
Anyway- thanks again Laura for the head's up, and if anyone is interested to discuss it a bit more, I'd welcome the intrusion into thesis writing.

Kind regards,

Matt

PhD candidate in Design
Art & Design Research Centre<http://www.shu.ac.uk/research/c3ri/>
Sheffield Hallam University

e matt.dexter at shu.ac.uk<mailto:matt.dexter at shu.ac.uk>
t +44 770 880 4341
tw @matt_dexter<https://twitter.com/matt_dexter>

Research funded by:
NIHR CLAHRC South Yorkshire<http://www.clahrc-sy.nihr.ac.uk>
- & -
Sheffield Hospitals Charity<http://www.sheffieldhospitalscharity.org.uk/>

On 7 Oct 2013, at 08:17, Laura James <laura.james at okfn.org<mailto:laura.james at okfn.org>> wrote:

Those of you not on the OSHW might be interested in a current thread there about regulatory issues.

This includes the requirements for food processing in the US, obtaining CE certification in Europe, implications of export controls for open-source hardware<http://mach30.org/ectf/>, and more. (list: http://lists.oshwa.org/listinfo/discuss)

I'm really interested in this issue - it's a big challenge to open hardware going mainstream - and connects to some of our related work, such as the new Product information working group which is just getting started: http://product.okfn.org/

Anyone else here interested in this area?

Laura

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