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Tag: Medical Device NPI & Commercialization

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TGA Guidance on Clinical Evidence for Supportive Devices

The new article describes in detail the aspects related to the clinical evidence required for meshes, patches, and tissue adhesives.  Table...

FDA Guidance on Ethical Considerations for Clinical Investigations Involving Children: Study Procedures and Summary

The new article highlights the key points related to study procedures in pediatric clinical investigations, and also provides a summary of the key points...

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