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About MDCG Cybersecurity en
This document provides guidance for medical device manufacturers on fulfilling cybersecurity requirements in the EU Medical Device Regulations. It outlines cybersecurity requirements in Annex I related to secure design and manufacturing, documentation, post-market surveillance, and vigilance. The guidance addresses risk management processes, minimum IT security measures, verification and validation, and documentation for users. It emphasizes a "secure by design" approach and joint responsibility across the supply chain to protect devices from unauthorized access and cyber threats.
Detailed Information
| Author: | ['Roxana'] |
|---|---|
| Publication Year: | 2021 |
| Pages: | 46 |
| Language: | English |
| Format: | |
| Price: | FREE |
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