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Articles tagged with: Cybersecurity
The NIS2 Directive Involves Medical Device Manufacturers
The NIS2 Directive imposes cybersecurity obligations on medical device manufacturers that are medium and large enterprises.
21/03/2025
Roberta Polisciano
Cybersecurity
Deadlines and exemptions
Manufacturers' duties
Medical Devices with Artificial Intelligence
Insights into the regulation of medical devices with integrated AI-based functions.
17/12/2024
Silvia Pozzi
Cybersecurity
Design
Software
MDR in Full Swing: Ranking of Lesser-Known Issues
The 5 less obvious aspects, ranked by impact, to manage in order to complete the MDR conformity assessment process.
28/11/2023
Davide Valtorta
Cybersecurity
Legacy device
Manufacturers' duties
Servizi
European Medical Device Regulation Consulting
CE Marking for Medical Devices
ISO 13485 and MDSAP Quality System
Technical Documentation
UDI and Eudamed Registration
Training Courses
European Medical Device Regulation Consulting
CE Marking for Medical Devices
ISO 13485 and MDSAP Quality System
Technical Documentation
UDI and Eudamed Registration
Training Courses
Home
Company
Work Method
Blog
Contact
Home
Company
Work Method
Blog
Contact
English
Services
European Medical Device Regulation Consulting
CE Marking for Medical Devices
ISO 13485 and MDSAP Quality System
Technical Documentation
UDI and Eudamed Registration
Training Courses
European Medical Device Regulation Consulting
CE Marking for Medical Devices
ISO 13485 and MDSAP Quality System
Technical Documentation
UDI and Eudamed Registration
Training Courses
Home
Company
Work Method
Blog
Contact
Home
Company
Work Method
Blog
Contact
English
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