Early Advice: Difference between revisions
(Created page with "Early advice (EA) describes a formal, structured and detailed interactions between a health technology developer and a consulting organization. This service within the R&D process usually prepares formal meetings between developers and regulatory authorities or HTA bodies (Scientific advice). The purpose is to provide specific guidance on clinical, regulatory or other issues that could impact the device's development pathway.") |
No edit summary |
||
| Line 1: | Line 1: | ||
Early advice (EA) describes a formal, structured and detailed interactions between a health technology developer and a consulting organization. | Early advice (EA) describes a formal, structured and detailed interactions between a health technology developer and a consulting organization. | ||
This service within the R&D process usually prepares formal meetings between developers and regulatory authorities or HTA bodies (Scientific advice). | This service within the R&D process usually prepares formal meetings between developers and regulatory authorities or HTA bodies ([[Scientific advice]]). | ||
The purpose is to provide specific guidance on clinical, regulatory or other issues that could impact the device's development pathway. | The purpose is to provide specific guidance on clinical, regulatory or other issues that could impact the device's development pathway. | ||
Revision as of 20:36, 17 July 2024
Early advice (EA) describes a formal, structured and detailed interactions between a health technology developer and a consulting organization.
This service within the R&D process usually prepares formal meetings between developers and regulatory authorities or HTA bodies (Scientific advice).
The purpose is to provide specific guidance on clinical, regulatory or other issues that could impact the device's development pathway.