BSI – White Papers

Załączniki

# Plik Wielkość pliku Pobrania
1 pdf BSI_md_en_60601_1_mdd_compliance_whitepaper_UK_EN 760 KB 45
2 pdf BSI_md_the_post_market_priority_whitepaper_UK_EN 94 KB 730
3 pdf Developing_and_Maintaining_a_QMS_for_IVDs_Web 366 KB 629
4 pdf digital-medicine-2018-report1-pages-final.original 418 KB 51
5 pdf General_Safety_and_Performance 199 KB 54
6 pdf Importers_distributors_and_assemblers 10 MB 133
7 pdf ISO_13485_Expert_Commentary___Online_version 96 KB 57
8 pdf Nanotechnology_White_paper_V2_WEB 367 KB 177
9 pdf Responisble_person_1 994 KB 53
10 pdf Smart_Support___Classification_changes 10 MB 96
11 pdf Smart_support_series_3 1 MB 93
12 pdf Vigilance_White_paper 372 KB 1950
13 pdf White_Paper___Cybersecurity_of_medical_devices 972 KB 52
14 pdf White_Paper___EU_MDR___Requirements_for_vigilance_reporting 818 KB 53
15 pdf White_Paper__Technical_Documentation_Web_v3 818 KB 47
16 pdf WP___Implementing_EU_MD_Regs 4 MB 61
17 pdf WP2__BSI_md_generating_clinical_evaluation_whitepaper_UK_EN 2 MB 48
18 pdf WP3___BSI_md_post_market_surveillance_whitepaper_UK_EN 331 KB 51
19 pdf WP4___BSI_md_fda_udi_system_final_rule_whitepaper_UK_EN 2 MB 55
20 pdf WP5___BSI_md_home_medical_devices_whitepaper_UK_EN 245 KB 47
21 pdf WP6___BSI_md_negotiating_innovation_and_regulatory_conundrum_whitepaper_UK_EN 381 KB 169
22 pdf WP7___BSI_md_usability_engineering_whitepaper_UK_EN 2 MB 53
23 pdf WP8___BSI_md_ISO_13485_proposed_changes_whitepaper_UK_EN 376 KB 50
24 pdf WP11___Differences_and_similarities_9001_13485 2 MB 227
25 pdf WP12_How_to_prepare_for_and_implement_the_upcoming_IVDR___Dos_and_Don___ts 444 KB 51
26 pdf bsi-md-mdr-best-practice-documentation-submissions-en-gb 488 KB 20201
27 pdf BSI-md-notifed-body-guide-brochure-UK-EN 408 KB 48