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About MDR and IEC TR 60601 4-5 Cybersecurity Requirements TUV SUD
This document discusses cybersecurity requirements for medical devices according to various standards and regulations. It outlines that the Medical Device Regulation requires manufacturers to implement cybersecurity risk management and protection measures throughout a device's lifecycle. The MDCG guidance specifies the MDR's cybersecurity requirements in more detail. Notified Bodies use checklists to validate that manufacturers meet requirements for security validation, risk assessment, and vulnerability handling. The document also reviews the FDA's additional cybersecurity considerations, which reference frameworks like NIST and ISO standards.
Detailed Information
| Author: | ['liesbeth alberts'] |
|---|---|
| Publication Year: | 2022 |
| Pages: | 35 |
| Language: | English |
| Format: | |
| Price: | FREE |
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