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Biomedical and Clinical Engineering
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17ABBZLN - Legislation in Health Care and Technical Standards
Downloads:
Lectures:
Attachment
Size
1. lecture - Legislation process, patients rights
1.15 MB
2. lecture - Putting product on market
709.39 KB
3. lecture - Metrology
761.94 KB
Lectures - link:
Lectures timeschedule:
https://harm.fbmi.cvut.cz/B231/17ABBZLN/lec
Exercises:
Attachment
Size
1. tutorial - Patients rights
504.18 KB
2. tutorial - Requirements on products
502.38 KB
3. tutorial - Classification of medical device
496.41 KB
3. tutorial - Guidance document - MDCG_2021_24
1.52 MB
Risk analysis
1.78 MB
Risk analysis - worksheet
18 KB
6. tutorial - Vigilance system
491.19 KB
6. tutorial - Vigilance system (FSN)
178.15 KB