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This TS will lay down requirements for risk management in the manufacture of health software products. In this context a manufacturer is "any natural or legal person with responsibility for the design, manufacture, packaging, or labelling of a health software product, assembling a system, or adapting a health software product before it is placed on the market and/or put into service, regardless of whether these operations are carried out by that person or on that person's behalf by a third party (ISO14971 modified)". A health software product is "any software for use in the health sector for health-related purposes but excluding software which is:
- necessary for the proper application of a medical device or
- which is an accessory to a medical device or
- which is a medical device in its own right.
The requirements will, as far as practicable, be in line for those applicable to medical devices such as in ISO 14971.
Reģistrācijas numurs (WIID)
28322
Darbības sfēra
This TS will lay down requirements for risk management in the manufacture of health software products. In this context a manufacturer is "any natural or legal person with responsibility for the design, manufacture, packaging, or labelling of a health software product, assembling a system, or adapting a health software product before it is placed on the market and/or put into service, regardless of whether these operations are carried out by that person or on that person's behalf by a third party (ISO14971 modified)". A health software product is "any software for use in the health sector for health-related purposes but excluding software which is:
- necessary for the proper application of a medical device or
- which is an accessory to a medical device or
- which is a medical device in its own right.
The requirements will, as far as practicable, be in line for those applicable to medical devices such as in ISO 14971.
