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Hi Manan,
IMHO there are several guidelines available (e.g. WHO, FDA), and I think they are pretty good. However, they are less developed as compared to guidelines on medications, as medical devices is a newer field. At my company we tend to handle 'uncertain'/'not-handled' situations in the general GCP manner, and write a note-to-file.
Not sure if this answers your question
IMHO there are several guidelines available (e.g. WHO, FDA), and I think they are pretty good. However, they are less developed as compared to guidelines on medications, as medical devices is a newer field. At my company we tend to handle 'uncertain'/'not-handled' situations in the general GCP manner, and write a note-to-file.
Not sure if this answers your question
Complete thread:
- Medical Devices manan 2011-03-31 06:56
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Medical DevicesCoja66 2011-03-31 15:07
Ing. Helmut Schütz