Dear forum members,
I am a newborn medical device quality consultant. My background is 15 years in R&D with Siemens Medical in Sweden.
My client makes a software package for importing, viewing, enhancing and storing images from dental X-ray systems or intra oral cameras.
They have a very flexible interface scheme, so there are a lot of image sources. Everything regarding X-rays and hardware is outside of the scope.
They feel the magic date of 3/21/2010 approaching so the march to the CE mark has started.
This is a *very* small company, so I try to streamline all procedures as much as I can. My mantra is: "Cover everything, but wafer thin".
I am working with the client to cover what I call the basic package for the essential requirements:
ISO 13485 Quality system
ISO 14971 Risk management
ISO 62304 Software lifecycle
IEC 62366 Usability
After this rather long preamble comes my question:
Is there any particular standard, imaging-related, that they have to cover?
I got my eyes on these two:
IEC 60601-2-54 Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
IEC 61223-2-5 Constancy tests - Image display devices
Are they relevant at all?
Is there anyone in the forum with experience from a similar system?
To summarize, I do not want to give my client a list of all remotely applicable standards, only what they really have to fulfil.
As a bonus, your feedback will be used as ammunition against my notified body, he didn't seem to sure about this topic either.