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EC Declaration of ConformityManufacturer:Device: Model: Description: Medical Device Classification:HeartSine Technologies Limited Canberra House 203 Airport Road West Belfast, BT3 9ED samaritan PAD
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How to fill out medical device classification
How to fill out medical device classification
01
Identify the regulatory authority in your country that oversees medical device classification.
02
Determine the intended use and technology of the medical device.
03
Refer to the classification guidelines provided by the regulatory authority.
04
Assess the risks associated with the medical device.
05
Assign a classification category based on the guidelines and risk assessment.
Who needs medical device classification?
01
Manufacturers of medical devices
02
Regulatory authorities
03
Healthcare providers
04
Patients
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What is medical device classification?
Medical device classification is a system used to categorize medical devices based on the level of risk they pose to patients and users.
Who is required to file medical device classification?
Manufacturers of medical devices are required to file for medical device classification.
How to fill out medical device classification?
Medical device classification can be filled out by providing relevant information about the device, such as intended use, design, materials, and risk assessment.
What is the purpose of medical device classification?
The purpose of medical device classification is to ensure appropriate regulatory oversight based on the level of risk associated with the device.
What information must be reported on medical device classification?
Information that must be reported on medical device classification includes device description, intended use, design features, risk assessment, and regulatory information.
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