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Medical Device Lifetime PDF

12 Pages·2024·English
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by ['Bhargav krishna']| 2024| 12 pages| English

About Medical Device Lifetime

The document discusses definitions of medical device lifetime from various sources, including the Medical Devices Regulation, guidance documents, and standards. It states that while the MDR does not define device lifetime specifically, it implies manufacturers must indicate a lifetime. Guidance documents and standards similarly indicate manufacturers should define an expected lifetime during which the device remains safe and effective. The document aims to promote consistency in approach and understanding of lifetime between manufacturers and notified bodies.

Detailed Information

Author:['Bhargav krishna']
Publication Year:2024
Pages:12
Language:English
Format:PDF
Price:FREE
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