BSI – White Papers

Załączniki

# Plik Rozmiar pliku Pobrania
1 pdf BSI_md_en_60601_1_mdd_compliance_whitepaper_UK_EN 760 KB 27
2 pdf BSI_md_the_post_market_priority_whitepaper_UK_EN 94 KB 707
3 pdf Developing_and_Maintaining_a_QMS_for_IVDs_Web 366 KB 377
4 pdf digital-medicine-2018-report1-pages-final.original 418 KB 33
5 pdf General_Safety_and_Performance 199 KB 38
6 pdf Importers_distributors_and_assemblers 10 MB 95
7 pdf ISO_13485_Expert_Commentary___Online_version 96 KB 38
8 pdf Nanotechnology_White_paper_V2_WEB 367 KB 99
9 pdf Responisble_person_1 994 KB 33
10 pdf Smart_Support___Classification_changes 10 MB 66
11 pdf Smart_support_series_3 1 MB 70
12 pdf Vigilance_White_paper 372 KB 1368
13 pdf White_Paper___Cybersecurity_of_medical_devices 972 KB 33
14 pdf White_Paper___EU_MDR___Requirements_for_vigilance_reporting 818 KB 36
15 pdf White_Paper__Technical_Documentation_Web_v3 818 KB 29
16 pdf WP___Implementing_EU_MD_Regs 4 MB 39
17 pdf WP2__BSI_md_generating_clinical_evaluation_whitepaper_UK_EN 2 MB 31
18 pdf WP3___BSI_md_post_market_surveillance_whitepaper_UK_EN 331 KB 33
19 pdf WP4___BSI_md_fda_udi_system_final_rule_whitepaper_UK_EN 2 MB 35
20 pdf WP5___BSI_md_home_medical_devices_whitepaper_UK_EN 245 KB 28
21 pdf WP6___BSI_md_negotiating_innovation_and_regulatory_conundrum_whitepaper_UK_EN 381 KB 151
22 pdf WP7___BSI_md_usability_engineering_whitepaper_UK_EN 2 MB 33
23 pdf WP8___BSI_md_ISO_13485_proposed_changes_whitepaper_UK_EN 376 KB 30
24 pdf WP11___Differences_and_similarities_9001_13485 2 MB 207
25 pdf WP12_How_to_prepare_for_and_implement_the_upcoming_IVDR___Dos_and_Don___ts 444 KB 30
26 pdf bsi-md-mdr-best-practice-documentation-submissions-en-gb 488 KB 19633
27 pdf BSI-md-notifed-body-guide-brochure-UK-EN 408 KB 27