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How Harmonized Standards Are The Answer To EU Notified Body Cybersecurity Work

 
• By Eliza Slawther

Few cybersecurity experts are available to assist during conformity assessments for medical devices, TEAM-NB has said. In light of this, its cybersecurity position paper recommends actions that will help notified bodies in their assessments.

CYBER KEYBOARD
• Source: Shutterstock

Ensuring that relevant standards, such as the IEC 81001-5-1, a standard that relates to health software, are adopted in a harmonized way is among one of TEAM-NB’s five suggestions to ensure that cybersecurity elements of conformity assessments by notified bodies are efficient but of a high quality.

Its other recommendations include: harmonizing the approach used for security risk assessments; adopting a harmonized approach for high-level penetration test requirements; ensuring cybersecurity is considered throughout the lifecycle of a...

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