Further to my recent posts on unannounced audits I have been thinking about how unannounced audits could play out in an area that becomes more and more important: standalone software.
Software medical devices
The majority of standalone software under the medical devices directive falls in the scope of rule 12 of Annex IX of the MDD and is therefore subject to self-certification (so no notified body oversight and no unannounced audits).
However, there is also a growing group of higher risk software that is [...]
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