ISO 13485 & EU MDR / MDR classification
Best MDR classification of a non-invasive, low power (8mW pulsed at 10% duty cycle) near infrared sensor applied to skin (hand web) in a transitory fashion for use over extended periods of time?
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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
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For the classification rules and help with the classification please see the following guidance:
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