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Software and Medical Devices - Team NB
- https://www.team-nb.org/wp-content/uploads/2015/05/nbmeddocuments/Recommendation-NB-MED-2_2-4_rev5_Software_and_Medical_Devices.pdf
- Software is regarded as a medical device when one or more of the circumstances given at (a) to (d) apply: The software is for a purpose explicitly mentioned in a Medical Device …
NBCG-MED DOCUMENTS - Welcome to Team NB | Team NB
- https://www.team-nb.org/nb-med-documents/
- NBCG-MED DOCUMENTS The documents displayed in this section are important documents edited in the framework of the NB-Med working group work. These …
Reporting of design changes and changes of the quality …
- http://meddev.info/_documents/R2_5_2-2_rev7.pdf
- Changes to the medical device included computer software (e.g. new functionalities, new algorithms for computing) which will change the specifications and / or performances of …
mdc medical device certification GmbH - Notified Bodies …
- https://www.mdc-ce.de/downloads/guidelines/notified-bodies-recommendations.html
- NB-MED documents comprise of recommendations accepted by the European Forum of Notified Bodies Medical Devices (NB-MED). These recommendations are are not …
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