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September 27, 2013
The EU Commission published “Commission Recommendation of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices.” This clarifies and strengthens the criteria for certifying (and auditing) notified bodies, and the criteria that the notified bodies have to use in assessing companies and products. The main changes...
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IEC 62366 Usability Process and Documentation

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