Medical Device

Medical Device 274 Questions

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What is the latest ISO 13485 version?

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What mean ISO?

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What should be included in risk management plan?

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What is the difference between ISO 13485 and ISO 14971?

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Does FDA recognize ISO 14971?

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What is the current version of ISO 14971?

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What is ISO 14971 and the process of the risk analysis defined in it?

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What is the difference between ISO and QMS?

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What does ISO 13485 mean?

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Is ISO 13485 mandatory?

549 viewsMedical Device

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Is ISO 14971 harmonized?

542 viewsMedical Device

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What is risk management medical devices?

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What are the 3 types of risks?

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Can severity be reduced in risk assessment?

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How are medical devices classified in general?

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What are the 6 mandatory procedures for ISO 9001?

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What are the 7 quality management principles?

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Who needs the ISO 13485 certification?

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Whose needed to be ISO certified?

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Who is ISO 13485 for?

575 viewsMedical Device

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